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Clinical Trials in the UK / NCT04818502
Active, not recruiting Observational

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

NCT04818502 · tracked via the Priya Life Science UK tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2021-05-04
Last updated
2026-05-28

Condition(s) studied

Mitral Valve Regurgitation

Investigational drug(s) / intervention(s)

Tendyne™ Mitral Valve System

Tendyne™ Mitral Valve System: Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.

Study summary

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use. 2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits. 3. Patient provides written informed consent prior to any study-specific procedure. Exclusion Criteria: 1. Patient is in another clinical study that may impact the follow-up or results of this study. 2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period. 3. Patient is under the age of 18 or age of legal consent. 4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Kepler University Hospital Linz Austria
UZ Gasthuisberg Leuven Belgium
University Hospital Olomouc Olomouc Czechia
IKEM Prague Prague Czechia
Hospital AGEL Trinec-Podlesi Třinec Czechia
Bordeaux University Hospital Bordeaux France
CHRU de Lille Lille France
Lyon University Hospital Lyon France
Rennes University Hospital Rennes France
Clinique Pasteur Toulouse France
Heart and Diabetes Center NRW Bad Oeynhausen Germany
German Heart Center Berlin Berlin Germany
University Hospital Bonn Bonn Germany
Universitätsclinic Cologne Cologne Germany
University Hospital Frankfurt Frankfurt Germany
University Heart Center Hamburg Hamburg Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel Germany
Leipzig Heart Center Leipzig Germany
University Medical Center Mainz Mainz Germany
German Heart Center Munich Munich Germany
Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern München Germany
Robert-Bosch Krankenhaus Stuttgart Germany
Shaare Zedek Jerusalem Jerusalem Israel
Sheba Medical Centre Tel Aviv Israel
Lancisi Cardiovascular Center - Politechnic University of Marcher Ancona Italy
AOU Civili Brescia Brescia Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
MUMC+ Maastricht Netherlands
Oslo University Hospital Oslo Norway
King Fahad Armed Forces Jeddah Saudi Arabia
King Fahad Medical City Riyadh Saudi Arabia
King Faisal Specialist Hospital & Research Center Riyadh Saudi Arabia
Clinico San Carlos Madrid Spain
University Hospital Basel, Clinic for Cardiac Surgery Basel Switzerland
Insel Bern Bern Switzerland
Royal Brompton Hospital London United Kingdom

More Abbott Medical Devices trials in the UK

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 NCT04818502 on ClinicalTrials.gov ↗ ← All trials in the UK