The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair (SK M-CLIP)

June 22, 2025 updated by: Segeberger Kliniken GmbH

A Prospective Follow-up Assessment in Bad Segeberg With Patients With Severe Mitral Regurgitation Undergoing Mitral Edge-to-edge Repair (M-TEER).

A Prospective Follow-up Assessment in Bad Segeberg for Patients with severe MR undergoing M-TEER

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective single center registry including all patients treated for severe mitral regurgitation (MR) with mitral edge-to-edge repair (M-TEER) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.

Study Type

Observational

Enrollment (Estimated)

2000

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
    • Schleswig Holstein
      • Bad Segeberg, Schleswig Holstein, Germany, 23795
        • Recruiting
        • Herzzentrum Segeberger Kliniken GmbH
        • Contact:

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 MR undergoing M-TEER

Description

Inclusion Criteria:

  • Patients with severe MR undergoing M-TEER

Exclusion Criteria:

  • None

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
Patients of severe MR undergoing M-TEER
Patients with severe mitral regurgitation undergoing transcatheter edge to edge repair (M-TEER)
Device: Transcatheter edge to edge repair
mitral valve transcatheter edge-to-edge repair
Other Names:
  • M TEER
  • Mitral Clip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of in-hospital and long-term cardiovascular adverse events in percent
Time Frame: 2 years
Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death, heart failure, rehospitalization)
2 years

Collaborators and Investigators

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

Sponsor

Segeberger Kliniken GmbH

Investigators

  • Study Director: Holger Nef, Prof., MD, Herzzentrum Segeberger Kliniken GmbH

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)

January 1, 2011

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

June 22, 2025

First Submitted That Met QC Criteria

June 22, 2025

First Posted (Estimated)

July 1, 2025

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 22, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK 113 - 168/11

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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