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Active, Not Recruiting

NCT Number: NCT04818502

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler University Hospital, Linz, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tendyne™ Mitral Valve System

Device

Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.

Other names: Transcatheter Mitral Valve Implantation (TMVI)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: RESOLVE-MR

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Mar 26, 2021
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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