TENDER: Tendyne European Experience Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Tendyne all patients treated with a Tendyne Mitral Valve System |
Device: Tendyne Mitral Valve System
Tendyne Mitral Valve System for mitral valve disease in a commercial setting
|
Outcome Measures
Primary Outcome Measures
- 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
- Rate of peri-procedural myocardial infarction [1 day]
Myocardial infarction during the index procedure
- Rate of conversion to open-heart surgery [1 day]
Conversion to open-heart surgery during the index procedure
- Rate of cardiac tamponade [1 day]
Cardiac Tamponade 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)
- 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)
- New York Heart Association (NYHA) functional class [30 days, 1 year and 3 years]
class I - IV
- 6-minute walk distance (6MWD) [30 days, 1 year and 3 years]
in m
- BNP/NT-proBNP level [30 days, 1 year and 3 years]
in pg/ml
- Mitral regurgitation severity grade [30 days, 1 year and 3 years]
grade 0/1+/2+/3+/4+
- Left and right ventricular dimensions [30 days, 1 year and 3 years]
left/right ventricular end-diastolic/-systolic diameter (in mm)
- 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
- 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
- Transprosthetic gradient [30 days, 1 year and 3 years]
in mmHg
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitaetsklinikum Linz | Linz | Austria | ||
| 2 | Universitaetsklinikum Wien | Wien | Austria | ||
| 3 | UZ Leuven | Leuven | Belgium | ||
| 4 | CHU de Bordeaux | Bordeaux | France | ||
| 5 | CHU de Lille | Lille | France | ||
| 6 | CHU Rennes | Rennes | France | ||
| 7 | Clinique Pasteur | Toulouse | France | ||
| 8 | Herz- und Diabeteszentrum NRW | Bad Oeynhausen | Germany | ||
| 9 | Deutsches Herzzentrum Berlin | Berlin | Germany | ||
| 10 | Universitaetsklinikum Bonn | Bonn | Germany | ||
| 11 | Universitätsklinikum Frankfurt | Frankfurt | Germany | ||
| 12 | UKE Hamburg | Hamburg | Germany | ||
| 13 | Universitaetsklinikum Koeln | Koeln | Germany | ||
| 14 | Herzentrum Leipzig | Leipzig | Germany | ||
| 15 | Universitätsmedizin Mainz | Mainz | Germany | ||
| 16 | DHZ München | Münich | Germany | ||
| 17 | Universitaetsklinikum Regensburg | Regensburg | Germany | ||
| 18 | Robert-Bosch-Krankenhaus Stuttgart | Stuttgart | Germany | ||
| 19 | Universitaetsklinikum Tuebingen | Tuebingen | Germany | ||
| 20 | ICH - Istituto Clinico Humanitas | Milan | Italy | ||
| 21 | University Hospital of Pisa | Pisa | Italy | ||
| 22 | University hospital Oslo | Oslo | Norway | ||
| 23 | Puerto de Hierro Madrid | Madrid | Spain | ||
| 24 | University hospital Madrid | Madrid | Spain | ||
| 25 | Hospital Clinico Valladolid | Valladolid | Spain | ||
| 26 | University Hospital of Vigo | Vigo | Spain | ||
| 27 | Karolinska University Stockholm | Stockholm | Sweden | ||
| 28 | Universitaetsspital Basel | Basel | Switzerland | ||
| 29 | Inselspital Bern | Bern | Switzerland | ||
| 30 | Royal Brompton London | London | United Kingdom |
Sponsors and Collaborators
- LMU Klinikum
Investigators
- Principal Investigator: Joerg Hausleiter, MD, LMU Klinikum Munich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-0110