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 (MOTOR)

May 20, 2025 updated by: Institut für Pharmakologie und Präventive Medizin

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 50733
        • Cellitinnen Hospital St. Vinzenz
        • Contact:
          • Jan-Malte Sinning, Prof.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with severe functional and mixed-type mitral regurgitation with optimized GMDT undergoing M-TEER (using the PASCAL system)

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
M-TEER patients
Patients with optimized guideline-directed medical therapy (GDMT) undergoing mitral transcatheter edge-to-edge repair (M-TEER, using the PASCAL system) for severe functional mitral regurgitation.
Procedure: Mitral transcatheter edge-to-edge repair
Mitral transcatheter edge-to-edge repair with the PASCAL system
Other Names:
  • M-TEER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New York Heart Association (NYHA) class
Time Frame: 6 months
NYHA class at baseline and 6-months follow-up
6 months
6-minute walk test
Time Frame: 6 months
6-minute walk test at baseline and 6-months follow-up
6 months

Collaborators and Investigators

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

Sponsor

Institut für Pharmakologie und Präventive Medizin

Investigators

  • Principal Investigator: Jan-Malte Sinning, Prof., Cellitinnen Hospital St. Vinzenz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The MOTOR Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no IPD shared with other researchers, sponsor owns database

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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