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

Mitral Valve Regurgitation Clinical Trial

— RESOLVE-MR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04818502
• Other study ID #: ABT-CIP-10313
• Status: Recruiting
• Start date: May 4, 2021
• Est. completion date: May 31, 2029

Study information

• Verified date: May 2023
• Source: Abbott Medical Devices
• Contact: Bart Janssens
• Phone: +32471723201
• Email: bart.janssens[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2029
• Est. primary completion date: May 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  France,  Germany,  Israel,  Italy,  Netherlands,  Norway,  Saudi Arabia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint for MR Elimination 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)	At 1 year
Secondary	Procedure Safety (PS)	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.	Day 0, at exit procedure room
Secondary	Freedom from LVOT Obstruction (LVOTO) at 30 Days	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.	At Day 30
Secondary	Freedom from Paravalvular Leak (PVL) at 30 Days	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.	At Day 30
Secondary	Left Ventricle Reverse Remodeling 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).	At 1 Year
Secondary	All-Cause Mortality at 30 Days	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.	At Day 30
Secondary	Long-term Device Durability (LDD) 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	At 5 Years