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

Active, not recruiting

• 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.

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Study Start: 2021-05-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-05-31
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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)

Kepler University Hospital; 🇦🇹 Linz, Austria

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

University Hospital Olomouc; 🇨🇿 Olomouc, Czechia

IKEM Prague; 🇨🇿 Praha, 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

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