There may be more paths forward than you’ve been told.
Too many patients hear “there’s nothing more we can do” — and stop looking. That’s exactly the moment the HIP exists for.
Clinical trials test treatments that aren’t available anywhere else yet — often for patients who don’t qualify for anything else. Even if a second or third opinion has left you without treatment options, you can ask your care team whether a clinical trial may be relevant.
Eligibility depends on your diagnosis, history, and location — the HIP team or your cardiologist can help you figure out if you qualify.
First, what is a clinical trial?
A clinical trial is a carefully supervised study of a treatment that is not yet available to everyone. It is not an experiment done to you. You are looked after by a full medical team, usually more closely than in ordinary care, and you can stop taking part at any point, for any reason.
Every trial has rules about who can join, based on your diagnosis, your history, and sometimes your age or where you live. That is why some people qualify and others do not. Taking part is free of charge for the treatment being studied.
For valve conditions that do not yet have an approved option, or for people who have been turned away everywhere else, a trial is sometimes the way to reach a treatment years before it is widely available.
Why We Keep This List
We keep track of these studies so you do not have to search through medical databases on your own.
RecruitingNAALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Edwards LifesciencesMultiple US sitesaortic
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Who can join
- child, adult, older adult
- Participants
- 1234
- Expected completion
- 2037-01
- Funded by
- industry
Conditions studied
Aortic Stenosis, Severe
What it measures
- Non-hierarchical composite of death and stroke, The number of patients that died or had a stroke, 1 year
Registry entry updated 2026-09-03
RecruitingNAALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Edwards LifesciencesMultiple US sitesaortic
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Who can join
- child, adult, older adult
- Participants
- 200
- Expected completion
- 2039-12
- Funded by
- industry
Conditions studied
Aortic Valve Insufficiency, Aortic Valve Stenosis
What it measures
- Non-hierarchical composite of death and stroke, The number of patients that died or had a stroke, 1 year
Registry entry updated 2026-07-27
RecruitingNAARTIST
JenaValve Technology, Inc.Multiple US sitesaortic
ARTIST
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Who can join
- child, adult, older adult
- Participants
- 1016
- Expected completion
- 2036-02
- Funded by
- industry
Conditions studied
Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Insufficiency
What it measures
- All stroke, Number of patients that had stroke, 12 months
- All-Cause Mortality, all-cause mortality at 12 months, 12 months
- unplanned cardiac rehospitalization, Number of patients who had unplanned cardiac rehospitalization, 12 months
Registry entry updated 2026-09-17
RecruitingNABELIEVE-IT
Cedars-Sinai Medical CenterOne US siteaortic
BELIEVE-IT
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review. The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options. The study patients will be followed with standard of care procedures for 10 years.
- Who can join
- adult, older adult
- Participants
- 250
- Expected completion
- 2037-02-01
- Funded by
- other
Conditions studied
Aortic Valve Stenosis, Bicuspid Aortic Valve
What it measures
- 1 year hierarchical composite outcome of death, disabling stroke, non-disabling stroke, valve reintervention, rehospitalization, unfavorable KCCQ (VARC 3), The primary endpoint will be analyzed by the Win ratio method14. That is, every patient in the TAVR group will be compared with every patient in the SAVR group to determine which pair has won. A win higher up in the hierarchy takes priority, so KCCQ gets used only for those pairs that were tied on the first 5 event components. Then KCCQ win is declared if the time-averaged change in KCCQ differs by 5 points or more. The win ratio= total wins on TAVR divided by total wins on SAVR, for which a 95% CI and p value is calculated., 1 year
Registry entry updated 2025-02-10
RecruitingBicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Cedars-Sinai Medical CenterOne US siteaortic
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
- Who can join
- adult, older adult
- Participants
- 2000
- Expected completion
- 2028-08-15
- Funded by
- other
Conditions studied
Bicuspid Aortic Valve
What it measures
- Death, Death from any cause, 1 month
- Death, Death from any cause, 1 year
- Death, Death from any cause, 2 years
- Death, Death from any cause, 3 years
- Death, Death from any cause, 4 years
- Death, Death from any cause, 5 years
Registry entry updated 2019-02-11
RecruitingNACAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
EmStop IncMultiple US sitesaortic
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.
- Who can join
- adult, older adult
- Participants
- 663
- Expected completion
- 2028-05
- Funded by
- industry
Conditions studied
Aortic Stenosis, Aortic Valve Disease, Aortic Valve Stenosis
What it measures
- Non-Inferiority, Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days, Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate
Working with
Bright Research Partners
Registry entry updated 2026-08-26
RecruitingNAENVISION
Abbott Medical DevicesMultiple US sitesaortic
ENVISION
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk. In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.
- Who can join
- adult, older adult
- Participants
- 1500
- Expected completion
- 2036-04
- Funded by
- industry
Conditions studied
Aortic Valve Disease, Aortic Valve Stenosis, Heart Disease Structural Disorder, Heart Valve Diseases
What it measures
- Composite of all-cause mortality or all stroke, Number of patients that had any of the outcome events., At 12 months post-procedure
Registry entry updated 2026-09-11
RecruitingILIT
Baylor Research InstituteOne US siteaortic
ILIT
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)
- Who can join
- adult, older adult
- Participants
- 50
- Expected completion
- 2027-10-01
- Funded by
- other
Conditions studied
Aortic Valve Stenosis, Iliac Disease
What it measures
- Acute technical success per the DISRUPT PAD definition at the time of intervention, Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion, At time of IVL procedure
- Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment, To know the efficacy of the treatment, At the time of TAVR procedure
Working with
Shockwave Medical, Inc.
Registry entry updated 2026-08-21
RecruitingNAJOURNEY
JC Medical, Inc., an affiliate of Edwards Lifesciences LLCMultiple US sitesaortic
JOURNEY
J-Valve Transfemoral Pivotal Study
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.
- Who can join
- adult, older adult
- Participants
- 194
- Expected completion
- 2032-02
- Funded by
- industry
Conditions studied
Aortic Valve Disease Mixed, Aortic Valve Regurgitation
What it measures
- All-cause mortality at 1 year, 1-year post-procedure
- The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3), Includes: * All-cause death * All stroke * VARC-3 type 2-4 bleeding * Major vascular, access-related, or cardiac structural complication * Acute kidney injury (AKI) stage 3 or 4 * New permanent pacemaker due to procedure-related conduction abnormalities * Surgery or intervention related to the device, 30-days post-procedure
Working with
Cardiovascular Research Foundation, New York, Minneapolis Heart Institute Foundation
Registry entry updated 2026-05-04
RecruitingNAMRI-TAVR
University Hospitals Cleveland Medical CenterOne US siteaortic
MRI-TAVR
MRI in Transcatheter Aortic Valve Replacement Patients
The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.
- Who can join
- adult, older adult
- Participants
- 90
- Expected completion
- 2026-12-30
- Funded by
- other
Conditions studied
Aortic Valve Stenosis
What it measures
- Effective orifice area (EOA), Change in effective orifice area (EOA) assessed by CMR between baseline and 1-year follow up (cm2), Baseline, 30-days and 1-year
- Mean gradient, Mean AV gradient assessed by CMR (mmHg), 1-year
- Peak gradient, Mean AV gradient assessed by CMR (mmHg), 1-year
Registry entry updated 2025-12-17
RecruitingNAPARTNER 3 Trial - Aortic Valve-in-Valve
Edwards LifesciencesMultiple US sitesaortic
PARTNER 3 Trial - Aortic Valve-in-Valve
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Who can join
- child, adult, older adult
- Participants
- 125
- Expected completion
- 2038-04
- Funded by
- industry
Conditions studied
Aortic Stenosis, Aortic Stenosis, Severe
What it measures
- Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke, Number of patients that died and/or had a stroke, 1 year
Registry entry updated 2024-05-10
RecruitingNAPROGRESS
Edwards LifesciencesMultiple US sitesaortic
PROGRESS
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
- Who can join
- older adult
- Participants
- 2250
- Expected completion
- 2037-06
- Funded by
- industry
Conditions studied
Aortic Stenosis, Calcific, Aortic Valve Stenosis
What it measures
- Primary Effectiveness Endpoint, Non-hierarchical composite of death, and heart failure hospitalization or event, 2 years
- Primary Safety Endpoint, Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention, 30 days
Registry entry updated 2025-12-17
RecruitingPROTECT-TAVR
Atlantic Health SystemMultiple US sitesaortic
PROTECT-TAVR
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are: 1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery? 2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group. Participants will: * Be screened for eligibility based on hemodynamic status and anatomical complexity * Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR * Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography
- Who can join
- adult, older adult
- Participants
- 30
- Expected completion
- 2027-06-30
- Funded by
- other
Conditions studied
Cardiogenic Shock, Cardiogenic Shock, ECMO, Severe Aortic Stenosis, Trans-catheter Aortic Valve Implantation
What it measures
- Primary Efficacy Endpoint: Composite of in-hospital death, intraprocedural resuscitated cardiac arrest or emergent cardiac surgery., From enrollment through hospital discharge (up to 30 days post-procedure)
Registry entry updated 2025-12-30
RecruitingRESTORE
Medtronic CardiovascularMultiple US sitesaortic
RESTORE
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Who can join
- adult, older adult
- Participants
- 225
- Expected completion
- 2027-11
- Funded by
- industry
Conditions studied
Aortic Stenosis
What it measures
- Primary Outcome Measure, 30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device, Early (30-days)
- Primary Outcome Measure, a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes, Late (1-year)
Registry entry updated 2026-05-28
RecruitingNASTAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
MiRusOne US siteaortic
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Who can join
- adult, older adult
- Participants
- 1025
- Expected completion
- 2028-04
- Funded by
- industry
Conditions studied
Aortic Stenosis, Symptomatic Severe Native Aortic Stenosis
What it measures
- All-cause mortality, all stroke and cardiovascular rehospitalization, The primary endpoint is the composite of all-cause mortality, all stroke, and cardiovascular rehospitalization (valve-related or procedure-related per VARC-3) at 1 year., 1 Year
Registry entry updated 2026-04-09
RecruitingTVTR
The Society of Thoracic SurgeonsMultiple US sitesaortic
TVTR
STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)
The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of aortic stenosis.
- Who can join
- adult, older adult
- Participants
- 16000
- Expected completion
- 2035-06
- Funded by
- other
Conditions studied
Aortic Valve Stenosis
What it measures
- Major adverse cardiac and cerebrovascular events, increase in the 30-day risk of adverse events among patients receiving TAVR, 30 day
Working with
American College of Cardiology
Registry entry updated 2022-08-25
RecruitingNABELIEVERS
Cedars-Sinai Medical CenterOne US siteaortic
BELIEVERS
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). The two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR). TAVR is a minimally invasive transcatheter procedure to treat aortic valve disease.. SAVR is involving the open chest surgery to replace the aortic valve. The devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA. Consented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure. Consented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms. The study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.
- Who can join
- adult, older adult
- Participants
- 1200
- Expected completion
- 2040-05-10
- Funded by
- other
Conditions studied
Bicuspid Aortic Valve Disease
What it measures
- To compare the safety and effectiveness of TAVR vs SAVR for the treatment of severe AS in patients with BAV, A hierarchical composite (assessed by Win ratio at latest available follow-up) of: 1. death, 2. disabling stroke, 3. non-disabling stroke, 4. valve reintervention, 5. rehospitalization†, 6. unfavorable KCCQ (VARC-3\*), 2 years post end of enrollment
Working with
Icahn School of Medicine at Mount Sinai, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Patient-Centered Outcomes Research Institute
Registry entry updated 2026-08-14
RecruitingNASHIELD
EnCompass Technologies, Inc.Multiple US sitesaortic
SHIELD
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)
- Who can join
- adult, older adult
- Participants
- 500
- Expected completion
- 2027-01
- Funded by
- industry
Conditions studied
Aortic Diseases, Aortic Stenosis Treated With TAVI
What it measures
- Major Adverse Cardiac and Cerebrovascular Events (MACCE), MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3), 30 days post procedure
- Total New Lesion Volume, Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI), 8-72 hours post procedure
Working with
Avania, Insight Medical Consulting
Registry entry updated 2025-11-20
RecruitingPHASE4CT TAVR
University of Maryland, BaltimoreOne US siteaortic
CT TAVR
CT TAVR Abdomen Study
A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.
- Who can join
- adult, older adult
- Participants
- 164
- Expected completion
- 2028-03-01
- Funded by
- other
Conditions studied
Transcatheter Aortic Valve Replacement
What it measures
- Diagnostic Quality of Images, 5-point Likert Scale, 18-24 months
Registry entry updated 2026-07-01
RecruitingENVISAGE
Montreal Heart InstituteOne US siteaorticmitraltricuspid
ENVISAGE
Enhanced Valves Interventions and Safe AI Generated End Results
This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes. It is based on the analysis of retrospective data from various specialized centers worldwide.
- Who can join
- adult, older adult
- Participants
- 21000
- Expected completion
- 2029-05
- Funded by
- other
Conditions studied
Heart Valve Disease, M-TEER, Mitraclip, T-TEER, TAVI, TMVI, TTVI, TriClip
What it measures
- Accuracy of transcatheter AI predictions, Validation of artificial intelligence algorithms for automatic segmentation of anatomic structures and imaging measurements, and prediction of the success of transcatheter interventions. Output of AI algorithm: * Sizes, types, and number of devices to be implanted * Device success * Percentage risk of permanent pacemaker implantation (for TAVI and TTVI) * Percentage risk of 30-day (para)valvular regurgitation for TAVI, and residual regurgitation for M-TEER and T-TEER * Single leaflet detachment for M-TEER and T-TEER * Left ventricular outflow tract obstruction for TMVI. Key success indicators: * First, independent retrospective validation dataset AI algorithms predict procedural outcome with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome. * Second independent retrospective dataset, perform a study to validate AI algorithms with \>90% accuracy and low inter-reader observer variability when compared to measured procedural outcome., Preoperative phase: automated segmentation and measurements compared with manual assessments; Postoperative phase at day 30: comparison of predicted results with actual clinical patient outcomes.
Working with
Centre Cardiologique du Nord, Centre Hospitalier Universitaire de Bordeaux, FRANCE, Clinique Pasteur Toulouse, Hospitaux Universitaires Paris Sud, Istituto clinico Città di Brescia, Materialise, Montefiore Medical Center, Pie Medical Imaging, Rennes University Hospital, San Raffaele University Hospital, Italy, Unity Health Toronto, University Hospital, Lille, University Hospital, Marseille, University Medical Center Mainz, Universitätsklinikum Hamburg-Eppendorf, Vancouver Hospital
Registry entry updated 2025-10-09
RecruitingNAFetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Mauro H. SchenoneOne US siteaortic
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).
- Who can join
- female, child, adult
- Participants
- 80
- Expected completion
- 2036-07
- Funded by
- other
Conditions studied
Hypoplastic Left Heart Syndrome
What it measures
- Number cases with pulmonary hypertension, Baseline
- Number of cases in which a biventricular repair was achieved, Baseline
- Number of cases in which the procedure was successful, Procedure success defined as the aortic valve was crossed and the balloon inflated with clear evidence of improvement of blood flow through the aortic valve and or new aortic valve regurgitation, Baseline
Registry entry updated 2026-05-01