Tendyne European Experience Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tendyne Mitral Valve System.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, France, Germany, Italy +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
TENDyne European expeRience Registry
Overview
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.
Interventions
- Device Tendyne Mitral Valve System
Tendyne Mitral Valve System for mitral valve disease in a commercial setting
Primary outcome measures
- Rate of procedural success [Time frame: 30 days]
Secondary outcome measures (12)
- Rate of peri-procedural myocardial infarction [Time frame: 1 day]
- Rate of conversion to open-heart surgery [Time frame: 1 day]
- Rate of cardiac tamponade [Time frame: 1 day]
- Rate of procedural mortality [Time frame: 1 day]
- Rate of technical success (cumulative endpoint according to MVARC) [Time frame: 1 day]
- Rate of device success (cumulative endpoint according to MVARC) [Time frame: 30 days, 1 year and 3 years]
- New York Heart Association (NYHA) functional class [Time frame: 30 days, 1 year and 3 years]
- 6-minute walk distance (6MWD) [Time frame: 30 days, 1 year and 3 years]
- BNP/NT-proBNP level [Time frame: 30 days, 1 year and 3 years]
- Mitral regurgitation severity grade [Time frame: 30 days, 1 year and 3 years]
- Left and right ventricular dimensions [Time frame: 30 days, 1 year and 3 years]
- Left ventricular function [Time frame: 30 days, 1 year and 3 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 12 centers
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen
- Deutsches Herzzentrum Berlin — Berlin
- Universitaetsklinikum Bonn — Bonn
- Universitaetsklinikum Koeln — Cologne
- Universitätsklinikum Frankfurt — Frankfurt
- UKE Hamburg — Hamburg
- Herzentrum Leipzig — Leipzig
- Universitätsmedizin Mainz — Mainz
- … and 4 more centers
France · 4 centers
- CHU de Bordeaux — Bordeaux
- CHU de Lille — Lille
- CHU Rennes — Rennes
- Clinique Pasteur — Toulouse
Spain · 4 centers
- Puerto de Hierro Madrid — Madrid
- University hospital Madrid — Madrid
- Hospital Clinico Valladolid — Valladolid
- University Hospital of Vigo — Vigo
Austria · 2 centers
- Universitaetsklinikum Linz — Linz
- Universitaetsklinikum Wien — Vienna
Italy · 2 centers
- ICH - Istituto Clinico Humanitas — Milan
- University Hospital of Pisa — Pisa
Switzerland · 2 centers
- Universitaetsspital Basel — Basel
- Inselspital Bern — Bern
Belgium · 1 center
- UZ Leuven — Leuven
Norway · 1 center
- University hospital Oslo — Oslo
Sweden · 1 center
- Karolinska University Stockholm — Stockholm
United Kingdom · 1 center
- Royal Brompton London — London
Publications
- Hell MM, Wild MG, Baldus S, Rudolph T, Treede H, Petronio AS, Modine T, Andreas M, Coisne A, Duncan A, Franco LN, Praz F, Ruge H, Conradi L, Zierer A, Anselmi A, Dumonteil N, Nickenig G, Pinon M, Barth S, Adamo M, Dubois C, Torracca L, Maisano F, Lurz P, von Bardeleben RS, Hausleiter J; TENDER Investigators. Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Ex PMID 38385922
Identifiers
NCT: NCT04898335 · 21-0110