Tendyne European Experience Registry

Study Overview
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Brief Summary
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TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

Detailed Description
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Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available. TENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes.

Official Title
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TENDyne European expeRience Registry

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: Tendyne Mitral Valve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements Exclusion Criteria: Patients not providing written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tendyne<br>all patients treated with a Tendyne Mitral Valve System | Device: Tendyne Mitral Valve System<br>* Tendyne Mitral Valve System for mitral valve disease in a commercial setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of procedural success | Device success (structural and functional); absence of death, stroke, life-threatening bleeding, major vascular or cardiac structural complications, acute kidney injury, myocardial infarction, heart failure and valve-related dysfunction requiring repeat procedure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of peri-procedural myocardial infarction | Myocardial infarction during the index procedure | 1 day | 
| Rate of conversion to open-heart surgery | Conversion to open-heart surgery during the index procedure | 1 day | 
| Rate of cardiac tamponade | Cardiac Tamponade during the index procedure | 1 day | 
| Rate of procedural mortality | Death during the index procedure | 1 day | 
| Rate of technical success (cumulative endpoint according to MVARC) | Absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery) Device success (according to MVARC): absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient < 5 mmHg) | 1 day | 
| Rate of device success (cumulative endpoint according to MVARC) | Absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient < 5 mmHg) | 30 days, 1 year and 3 years | 
| New York Heart Association (NYHA) functional class | class I - IV | 30 days, 1 year and 3 years | 
| 6-minute walk distance (6MWD) | in m | 30 days, 1 year and 3 years | 
| BNP/NT-proBNP level | in pg/ml | 30 days, 1 year and 3 years | 
| Mitral regurgitation severity grade | grade 0/1+/2+/3+/4+ | 30 days, 1 year and 3 years | 
| Left and right ventricular dimensions | left/right ventricular end-diastolic/-systolic diameter (in mm) | 30 days, 1 year and 3 years | 
| Left ventricular function | LVEF in percent | 30 days, 1 year and 3 years | 
| Right ventricular function | TAPSE in mm | 30 days, 1 year and 3 years | 
| Pulmonary artery pressure | in mmHg | 30 days, 1 year and 3 years | 
| Tricuspid regurgitation severity grade | grade 1-5 | 30 days, 1 year and 3 years | 
| Transprosthetic gradient | in mmHg | 30 days, 1 year and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tendyne, mitral regurgitation, transcatheter mitral valve replacement