Tendyne European Experience Registry
- Conditions
- Mitral Regurgitation
- Interventions
- Device: Tendyne Mitral Valve System
- Registration Number
- NCT04898335
- Lead Sponsor
- LMU Klinikum
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- Patients not providing written informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tendyne Tendyne Mitral Valve System all patients treated with a Tendyne Mitral Valve System
- Primary Outcome Measures
Name Time Method Rate of procedural success 30 days 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
- Secondary Outcome Measures
Name Time Method BNP/NT-proBNP level 30 days, 1 year and 3 years in pg/ml
Left and right ventricular dimensions 30 days, 1 year and 3 years left/right ventricular end-diastolic/-systolic diameter (in mm)
Pulmonary artery pressure 30 days, 1 year and 3 years in mmHg
Tricuspid regurgitation severity grade 30 days, 1 year and 3 years grade 1-5
Rate of conversion to open-heart surgery 1 day Conversion to open-heart surgery during the index procedure
Rate of procedural mortality 1 day Death during the index procedure
Rate of technical success (cumulative endpoint according to MVARC) 1 day 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)
6-minute walk distance (6MWD) 30 days, 1 year and 3 years in m
Rate of cardiac tamponade 1 day Cardiac Tamponade during the index procedure
Rate of peri-procedural myocardial infarction 1 day Myocardial infarction during the index procedure
Mitral regurgitation severity grade 30 days, 1 year and 3 years grade 0/1+/2+/3+/4+
Transprosthetic gradient 30 days, 1 year and 3 years in mmHg
New York Heart Association (NYHA) functional class 30 days, 1 year and 3 years class I - IV
Rate of device success (cumulative endpoint according to MVARC) 30 days, 1 year and 3 years 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)
Left ventricular function 30 days, 1 year and 3 years LVEF in percent
Right ventricular function 30 days, 1 year and 3 years TAPSE in mm
Trial Locations
- Locations (30)
UZ Leuven
🇧🇪Leuven, Belgium
Universitaetsklinikum Wien
🇦🇹Wien, Austria
Universitaetsklinikum Linz
🇦🇹Linz, Austria
Inselspital Bern
🇨🇭Bern, Switzerland
CHU de Bordeaux
🇫🇷Bordeaux, France
Royal Brompton London
🇬🇧London, United Kingdom
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Robert-Bosch-Krankenhaus Stuttgart
🇩🇪Stuttgart, Germany
Hospital Clinico Valladolid
🇪🇸Valladolid, Spain
University hospital Madrid
🇪🇸Madrid, Spain
University hospital Oslo
🇳🇴Oslo, Norway
Karolinska University Stockholm
🇸🇪Stockholm, Sweden
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitätsmedizin Mainz
🇩🇪Mainz, Germany
Herzentrum Leipzig
🇩🇪Leipzig, Germany
ICH - Istituto Clinico Humanitas
🇮🇹Milan, Italy
Puerto de Hierro Madrid
🇪🇸Madrid, Spain
University Hospital of Pisa
🇮🇹Pisa, Italy
Clinique Pasteur
🇫🇷Toulouse, France
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
CHU de Lille
🇫🇷Lille, France
CHU Rennes
🇫🇷Rennes, France
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, Germany
Universitaetsspital Basel
🇨🇭Basel, Switzerland
Universitaetsklinikum Koeln
🇩🇪Koeln, Germany
DHZ München
🇩🇪Münich, Germany
Universitaetsklinikum Regensburg
🇩🇪Regensburg, Germany
University Hospital of Vigo
🇪🇸Vigo, Spain
UKE Hamburg
🇩🇪Hamburg, Germany