Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06702527

Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy

A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Mitral Regurgitation Functional Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases M-TEER Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cellitinnen Hospital St. Vinzenz

Cologne, North Rhine-Westphalia, 50733, Germany

Location contact

Jan-Malte Sinning, Prof.

CONTACT

About this study

Mitral transcatheter edge-to-edge repair (M-TEER) has become an important therapy in the management of severe functional mitral regurgitation (FMR).

These patients often have left ventricular dilatation with associated left ventricular failure and undergo intervention after guideline-directed medical therapy (GDMT) is optimised.

However, many patients cannot tolerate maximal doses of these drugs, some of which are potent vasodilators, due to the potential for hypotension and other side effects.

After M-TEER, with significant reduction of valve regurgitation, and a consequent improvement in systemic blood pressure and left ventricular function, it may be possible to further optimize GDMT and thus improve patients' clinical outcomes.

This pilot registry will be conducted in up to 4 German centres with a minimum annual volume of ~ 50 M-TEER procedures aiming for an environment of 100 patients.

This registry aims to:

  • document the extent of suboptimal GDMT in patients undergoing M-TEER for severe FMR and to assess the potential to improve care towards maximal recommended medical therapy.
  • compare 6- and 12-months heart failure (HF) hospitalization post-procedure compared to 12- and 6-months historical HF hospitalisation prior the index procedure. Functional status (NYHA class, 6-minute walk test) to be assessed at baseline and at 6 months follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • mitral transcatheter edge-to-edge repair (M-TEER) patients treated with the PASCAL system (≥ 18 years) as per the current approved indication and local Heart Team decision
  • Severe functional and mixed-type mitral regurgitation with LV-EF < 50%
  • Patient with optimized guideline-directed medical therapy (GDMT): A minimum of 3 points in the pre-defined GMDT scoring system
  • Provision of written informed consent

Exclusion criteria

  • Degenerative mitral regurgitation
  • Emergency procedure
  • Re-do or concomitant (mitral/tricuspid) procedures
  • Patients on maximum dose GDMT
  • Atrial functional mitral regurgitation (FMR)
  • Coronary revascularisation within the last 3 months
  • Pregnant woman

Treatment and study plan

Mitral transcatheter edge-to-edge repair

Procedure

Mitral transcatheter edge-to-edge repair with the PASCAL system

Other names: M-TEER

Primary outcomes

  1. Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)

    Time frame: 6 and 12 months

    Number of 6- and 12-months heart failure (HF) hospitalizations post M-TEER procedure compared to 12- and 6-months historical HF hospitalization prior the index procedure

Secondary outcomes

  1. New York Heart Association (NYHA) class

    Time frame: 6 months

    NYHA class at baseline and 6-months follow-up

  2. 6-minute walk test

    Time frame: 6 months

    6-minute walk test at baseline and 6-months follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia M Lüske, PhD

CONTACT

[email protected]

+49 4471 8503324

Marie F Zielinski

CONTACT

[email protected]

+49 4471 8503326

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Registry information

Official study title

Optimizing Clinical Outcomes in Patients Undergoing M-TEER for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy - The MOTOR Registry

Acronym: MOTOR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
May 23, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.