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.
Active, not recruitingALTERRA Post-Approval Study
Edwards LifesciencesMultiple US sitespulmonary
ALTERRA Post-Approval Study
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Who can join
- child, adult, older adult
- Participants
- 150
- Expected completion
- 2035-07
- Funded by
- industry
Conditions studied
Complex Congenital Heart Defect, Pulmonary Regurgitation, Pulmonary Valve Insufficiency, RVOT Anomaly, Tetralogy of Fallot
What it measures
- Acute Device Success, Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation, 24 hours post-procedure
Registry entry updated 2025-11-04
Active, not recruitingNAALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Edwards LifesciencesMultiple US sitespulmonary
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
- Who can join
- child, adult, older adult
- Participants
- 86
- Expected completion
- 2032-06
- Funded by
- industry
Conditions studied
Congenital Heart Disease, Pulmonary Disease, Pulmonary Regurgitation, Tetralogy of Fallot, Transcatheter Pulmonary Valve Replacement (TPVR)
What it measures
- Main Cohort: THV Dysfunction, Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE, 6 months
- PDS Registry: Acute PDS Success, Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation, 24 hours
Registry entry updated 2025-09-25
RecruitingNACOMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Edwards LifesciencesMultiple US sitespulmonary
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
- Who can join
- child, adult, older adult
- Participants
- 108
- Expected completion
- 2031-06
- Funded by
- industry
Conditions studied
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve Insufficiency
What it measures
- THV dysfunction, Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE, 1 year
Registry entry updated 2026-07-23
Active, not recruitingCOMPASSION S3 Post-Approval Study
Edwards LifesciencesMultiple US sitespulmonary
COMPASSION S3 Post-Approval Study
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
- Who can join
- child, adult, older adult
- Participants
- 150
- Expected completion
- 2030-08
- Funded by
- industry
Conditions studied
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve Insufficiency, Pulmonary Valve; Obstruction
What it measures
- Device Success, Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient \< 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of explant at 24 hours post-implantation, Discharge, expected to be within 1-5 days post-procedure
Registry entry updated 2026-02-03
Active, not recruitingNAThe Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
Medtronic Heart ValvesMultiple US sitespulmonary
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
- Who can join
- child, adult, older adult
- Participants
- 86
- Expected completion
- 2031-02
- Funded by
- industry
Conditions studied
Congenital Heart Disease, Pulmonary Regurgitation, RVOT Anomaly, Tetrology of Fallot
What it measures
- Freedom From Procedure- or Device-related Mortality at 30 Days., The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure., 30 days
- Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months, Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%, 6 months
Registry entry updated 2025-09-19
RecruitingNAPROTEUS
Venus MedTech (HangZhou) Inc.Multiple US sitespulmonary
PROTEUS
VenusP-Valve Pivotal Study (PROTEUS STUDY)
A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.
- Who can join
- child, adult, older adult
- Participants
- 60
- Expected completion
- 2034-08-30
- Funded by
- industry
Conditions studied
Pulmonary Regurgitation
What it measures
- The rate of procedure or device related mortality at the 30 days follow-up visit post procedure, Freedom from procedure or device related mortality at 30 days, At 30 Days Post Procedure
- The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure, Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: 1. No more than mild regurgitation measured by CMR; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg., At 6 Months Post Procedure
Registry entry updated 2025-02-28
Active, not recruitingNAEvaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
W.L.Gore & AssociatesMultiple US sitespulmonary
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Who can join
- child, adult, older adult
- Participants
- 15
- Expected completion
- 2030-03
- Funded by
- industry
Conditions studied
Heart Defects, Congenital, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Tetralogy of Fallot
What it measures
- Valve-related mortality and device-related re-intervention, The composite of valve-related mortality and device-related re-intervention measured at 6 months post-procedure, 6 months
Registry entry updated 2026-02-05
Active, not recruitingNAHarmony TPV Post-Approval Study
Medtronic CardiovascularMultiple US sitespulmonary
Harmony TPV Post-Approval Study
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Who can join
- child, adult, older adult
- Participants
- 174
- Expected completion
- 2035-03
- Funded by
- industry
Conditions studied
Congenital Heart Disease, Pulmonary Regurgitation, RVOT Anomaly, Tetrology of Fallot
What it measures
- Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:, * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%, 6 months
Registry entry updated 2026-06-02