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

May 24, 2026 updated by: Abbott Medical Devices

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects of all genders from the population of patients meeting indications for a Tendyne implant as stated within the IFU. Subjects must meet all eligibility criteria and provide written informed consent.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint for MR Elimination at 1 Year
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Safety (PS)
Time Frame: 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.
Day 0, at exit procedure room
Freedom from LVOT Obstruction (LVOTO) at 30 Days
Time Frame: 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.
At Day 30
Freedom from Paravalvular Leak (PVL) at 30 Days
Time Frame: 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.
At Day 30
Left Ventricle Reverse Remodeling at 1 Year
Time Frame: 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
All-Cause Mortality at 30 Days
Time Frame: 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.
At Day 30
Long-term Device Durability (LDD) at 5 Years
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Actual)

April 4, 2024

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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