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Conditions studied

Cardiovascular Diseases (CVD), Heart Valve Diseases, Randomized Controlled Trial (RCT), Severe Heart Valve Disease, Symptomatic Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation

What it measures

• Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) \* 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life., 12 months post procedure
• Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA), The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients., 12 months post procedure
• Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention, All-cause mortality, heart failure hospitalization and non-elective tricuspid valve reintervention will be adjudicated by a Clinical Events Committee., 12 months post-procedure
• Composite of major adverse events (MAEs), Composite of major adverse events consist of the following: * Cardiovascular mortality * Stroke * Life-threatening bleeding * Major vascular complications * Major cardiac structural complications * Stage 2 or 3 acute kidney injury * Myocardial infarction or coronary ischemia * Device-related obstruction of forward flow * Device-related pulmonary embolism * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention, 30 days post-procedure

Conditions studied

Tricuspid Regurgitation (TR)

What it measures

• Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points, All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status., At 30-day follow-up
• Rate of Peri-Procedural Adverse Events, Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding, Through 30 days post-procedure
• Tricuspid Regurgitation (TR) grade less than or equal to moderate, At 30-day follow-up

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders

What it measures

• Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs, Baseline to 1 month after implant
• Changes in functional capacity (6-minute walk test), Changes in functional capacity (6-minute walk test), Baseline to 1 month after implant
• Changes in in quality of life (KCCQ score), Changes in in quality of life (KCCQ score). A higher score indicates worsening quality of life outcomes, Baseline to 1 month after implant
• Changes in symptom status (NYHA class), Changes in symptom status (NYHA class), Baseline to 1 month after implant
• The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC)., Implant to 30 days post-procedure

Conditions studied

Tricuspid Valve Regurgitation

What it measures

• Absence of device or procedure related major adverse events, 30 days
• Change in TR grade from baseline, 30 days

Conditions studied

Heart Valve Diseases, Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency

What it measures

• Freedom from device or procedure related MAEs, * Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism, At 30 days

Conditions studied

Tricuspid Regurgitation

What it measures

• Technical success, Successful valve implantation, During procedure

Conditions studied

Tricuspid Regurgitation Functional

What it measures

• Freedom from device or procedure-related mortality, Freedom from mortality determined to be primarily caused by the device or procedure in the primary endpoint cohort. Events adjudicated by a Clinical Events Committee (CEC)., 30 days post-adjustment

Conditions studied

Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency

What it measures

• Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score), Comparison of number of participants with composite endpoint events between experimental and active comparator arms, 6 months

Conditions studied

Tricuspid Regurgitation

What it measures

• Freedom from device-related complications, Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications, 30 days after the index procedure
• Reduction in Tricuspid Regurgitation Severity, Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed, 30 days after the index procedure

Working with

The Cleveland Clinic, University Hospital, Bordeaux, University of Toronto

Conditions studied

Tricuspid Regurgitation, Tricuspid Regurgitation Functional

What it measures

• Rate of Major Adverse Events [Safety endpoint], Rate of device or procedure-related Major Adverse Events (MAEs) And Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure, at the end of the procedure, at discharge - typically within a week, and 30 days
• Technical Performance, Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC \[at the end of the procedure\] And No need for re-intervention due to device valve regurgitation or para-stent leak \[at discharge, and 30 days\], at the end of the procedure, at discharge - typically within a week, and 30 days

Working with

Innoventric Inc.

Conditions studied

Tricuspid Regurgitation (TR)

What it measures

• Rate of Composite Clinical Success, Percentage (%) of participants achieving composite clinical success at 12 months. Composite clinical success is defined as meeting all of the following criteria: Patient survival, Free from heart failure hospitalization, No tricuspid valve surgery or percutaneous intervention, 12 Months Post-Procedure
• Rate of Major Adverse Events (MAE), Rate of Major Adverse Events (MAE) at 30 days consisting of the following components: * Cardiovascular Mortality * Myocardial Infarction (MI), periprocedural and spontaneous * All Stroke, disabling and non-disabling * New need for renal replacement therapy * Severe bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\] * Non-elective tricuspid valve re-intervention, surgery or transcatheter * Major access site and vascular complications * Major cardiac structural complications * Device-related pulmonary embolism * Arrhythmia and conduction disorders requiring permanent pacing, 30 Day Post-Procedure

Conditions studied

Cardiovascular Diseases, Heart Valve Diseases, Tricuspid Valve Regurgitation

What it measures

• Composite of MAE, Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications., 30 day post-intervention
• Device Success, Device success defined as a reduction in tricuspid regurgitation immediately post-intervention, immediately post-intervention

Conditions studied

Severe Tricuspid Regurgitation

What it measures

• Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention, 1-year post-procedure
• Rate of Major Adverse Events (MAE), 30-days post-procedure

Conditions studied

Tricuspid Regurgitation

What it measures

• Change in TR from baseline, Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging., During procedure
• Rate of device-related serious adverse events, Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure, Up to 30 days
• Rate of procedural success, Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction, Up to 30 days
• Rate of technical success, Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system., During procedure

Conditions studied

Heart Failure, Interventional Cardiology, Structural Heart Disease, Tricuspid Regurgitation

What it measures

• Mortality Rate, The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group., 1 Year

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