Tendyne European Experience Registry

NCT04898335 · tracked via the Priya Life Science Spain tracker

Sponsor

LMU Klinikum

Phase

Observational

Started

2021-04-15

Last updated

2021-05-24

Condition(s) studied

Mitral Regurgitation

Investigational drug(s) / intervention(s)

Tendyne Mitral Valve System

Tendyne Mitral Valve System: Tendyne Mitral Valve System for mitral valve disease in a commercial setting

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (30)

Facility	City	Region	Status
Universitaetsklinikum Linz	Linz	Austria	Recruiting
Universitaetsklinikum Wien	Vienna	Austria	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
CHU de Bordeaux	Bordeaux	France	Not Yet Recruiting
CHU de Lille	Lille	France	Recruiting
CHU Rennes	Rennes	France	Not Yet Recruiting
Clinique Pasteur	Toulouse	France	Recruiting
Herz- und Diabeteszentrum NRW	Bad Oeynhausen	Germany	Recruiting
Deutsches Herzzentrum Berlin	Berlin	Germany	Recruiting
Universitaetsklinikum Bonn	Bonn	Germany	Recruiting
Universitaetsklinikum Koeln	Cologne	Germany	Recruiting
Universitätsklinikum Frankfurt	Frankfurt	Germany	Recruiting
UKE Hamburg	Hamburg	Germany	Recruiting
Herzentrum Leipzig	Leipzig	Germany	Not Yet Recruiting
Universitätsmedizin Mainz	Mainz	Germany	Recruiting
DHZ München	Münich	Germany	Recruiting
Universitaetsklinikum Regensburg	Regensburg	Germany	Not Yet Recruiting
Robert-Bosch-Krankenhaus Stuttgart	Stuttgart	Germany	Not Yet Recruiting
Universitaetsklinikum Tuebingen	Tübingen	Germany	Recruiting
ICH - Istituto Clinico Humanitas	Milan	Italy	Recruiting
University Hospital of Pisa	Pisa	Italy	Recruiting
University hospital Oslo	Oslo	Norway	Recruiting
Puerto de Hierro Madrid	Madrid	Spain	Recruiting
University hospital Madrid	Madrid	Spain	Recruiting
Hospital Clinico Valladolid	Valladolid	Spain	Recruiting
University Hospital of Vigo	Vigo	Spain	Recruiting
Karolinska University Stockholm	Stockholm	Sweden	Not Yet Recruiting
Universitaetsspital Basel	Basel	Switzerland	Not Yet Recruiting
Inselspital Bern	Bern	Switzerland	Recruiting
Royal Brompton London	London	United Kingdom	Recruiting

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Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial Recruiting

MiCLASP Post Market Clinical Follow-Up (PMCF) Study Active, not recruiting

MitraClip EXPAND G4 Study Active, not recruiting

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04898335 on ClinicalTrials.gov ↗ ← All trials in Spain