RESOLVE-MR: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04818502

Collaborator

(none)

200

Enrollment

Locations

96.9

Anticipated Duration (Months)

5.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Regurgitation	Device: Tendyne™ Mitral Valve System

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)

Actual Study Start Date :

May 4, 2021

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2029

Outcome Measures

Primary Outcome Measures

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

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.
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).
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Kepler University Hospital	Linz	Austria
2	UZ Gasthuisberg	Leuven	Belgium
3	University Hospital Olomouc	Olomouc	Czechia
4	IKEM Prague	Praha	Czechia
5	Hospital AGEL Trinec-Podlesi	Třinec	Czechia
6	Bordeaux University Hospital	Bordeaux	France
7	CHRU de Lille	Lille	France
8	Lyon University Hospital	Lyon	France
9	Rennes University Hospital	Rennes	France
10	Clinique Pasteur	Toulouse	France
11	Heart and Diabetes Center NRW	Bad Oeynhausen	Germany
12	German Heart Center Berlin	Berlin	Germany
13	University Hospital Bonn	Bonn	Germany
14	University Hospital Frankfurt	Frankfurt	Germany
15	University Heart Center Hamburg	Hamburg	Germany
16	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel	Germany
17	Universitätsclinic Cologne	Köln	Germany
18	Leipzig Heart Center	Leipzig	Germany
19	University Medical Center Mainz	Mainz	Germany
20	German Heart Center Munich	Munich	Germany
21	Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern	München	Germany
22	Robert-Bosch Krankenhaus	Stuttgart	Germany
23	Shaare Zedek Jerusalem	Jerusalem	Israel
24	Sheba Medical Centre	Tel Aviv	Israel
25	Lancisi Cardiovascular Center - Politechnic University of Marcher	Ancona	Italy
26	AOU Civili Brescia	Brescia	Italy
27	Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
28	MUMC+	Maastricht	Netherlands
29	Oslo University Hospital	Oslo	Norway
30	King Fahad Armed Forces	Jeddah	Saudi Arabia
31	King Fahad Medical City	Riyadh	Saudi Arabia
32	King Faisal Specialist Hospital & Research Center	Riyadh	Saudi Arabia
33	Clinico San Carlos	Madrid	Spain
34	University Hospital Basel, Clinic for Cardiac Surgery	Basel	Switzerland
35	Insel Bern	Bern	Switzerland
36	Royal Brompton Hospital	London	United Kingdom