Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
- Conditions
- Mitral Valve Regurgitation
- Registration Number
- NCT04818502
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
- Detailed Description
The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support the CE Mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting.
The objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
- 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.
- Patient provides written informed consent prior to any study-specific procedure.
- Patient is in another clinical study that may impact the follow-up or results of this study.
- Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
- Patient is under the age of 18 or age of legal consent.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint for MR Elimination at 1 Year At 1 year The primary endpoint MR Elimination will be assessed at one year post-procedure and is defined as original Tendyne valve remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and MR \< Grade I (mild, measured by Echocardiographic Core Lab)
- Secondary Outcome Measures
Name Time Method All-Cause Mortality at 30 Days At Day 30 This will be assessed at 30 days post-procedure and is defined as the proportion of subjects who die within 30 days post-procedure for any cause.
Procedure Safety (PS) Day 0, at exit procedure room This will be assessed at exit from the procedure room and is defined as freedom from procedural mortality, unplanned surgical or interventional procedures related to the Tendyne valve or access procedure.
Freedom from LVOT Obstruction (LVOTO) at 30 Days At Day 30 This will be assessed at 30 days post-procedure and is defined as mean LVOT gradient increase \<10 mmHg from baseline (measured by the Echo Core Lab), and free of unplanned intervention for LVOTO.
Freedom from Paravalvular Leak (PVL) at 30 Days At Day 30 This will be assessed at 30 days post-procedure and is defined as the Tendyne prosthesis PVL ≤ mild (Grade I), as measured by the Echo Core Lab.
Long-term Device Durability (LDD) at 5 Years At 5 Years This will be assessed at 5 years post-procedure and is defined as original Tendyne device remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and free from Structural Valve Dysfunction
Left Ventricle Reverse Remodeling at 1 Year At 1 Year This will be assessed at 1-year post-procedure and is defined as the proportion of survivors at one year with baseline Left Ventricle End Diastolic Volume Index (LVEDVi) \> 96ml/m2 that experience 10% or greater reduction in LVEDVi at one year (assessed by the Echo Core lab).
Trial Locations
- Locations (36)
MUMC+
🇳🇱Maastricht, Netherlands
King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
Kepler University Hospital
🇦🇹Linz, Austria
King Faisal Specialist Hospital & Research Center
🇸🇦Riyadh, Saudi Arabia
Oslo University Hospital
🇳🇴Oslo, Norway
King Fahad Armed Forces
🇸🇦Jeddah, Saudi Arabia
University Hospital Basel, Clinic for Cardiac Surgery
🇨🇭Basel, Switzerland
Insel Bern
🇨🇭Bern, Switzerland
UZ Gasthuisberg
🇧🇪Leuven, Belgium
IKEM Prague
🇨🇿Praha, Czechia
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Bordeaux University Hospital
🇫🇷Bordeaux, France
Hospital AGEL Trinec-Podlesi
🇨🇿Třinec, Czechia
CHRU de Lille
🇫🇷Lille, France
University Hospital Bonn
🇩🇪Bonn, Germany
Rennes University Hospital
🇫🇷Rennes, France
Lyon University Hospital
🇫🇷Lyon, France
German Heart Center Berlin
🇩🇪Berlin, Germany
Heart and Diabetes Center NRW
🇩🇪Bad Oeynhausen, Germany
Clinique Pasteur
🇫🇷Toulouse, France
University Heart Center Hamburg
🇩🇪Hamburg, Germany
University Hospital Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Leipzig Heart Center
🇩🇪Leipzig, Germany
Universitätsclinic Cologne
🇩🇪Köln, Germany
German Heart Center Munich
🇩🇪Munich, Germany
University Medical Center Mainz
🇩🇪Mainz, Germany
Robert-Bosch Krankenhaus
🇩🇪Stuttgart, Germany
Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern
🇩🇪München, 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
Clinico San Carlos
🇪🇸Madrid, Spain
Royal Brompton Hospital
🇬🇧London, United Kingdom