Recruiting

Mitral Repair

Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Code:

NCT05332782

Conditions

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).

Conditions

Mitral Regurgitation

Study ID

NCT05332782

Start date

Mar 1, 2022

Status verified date

Apr, 2022

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • clinically significant primary mitral regurgitation
  • patient underwent M-TEER
  • echocardiography data at baseline, procedure and follow-up
  • follow-up of at least 12 months

Exclusion Criteria

  • age under 18 years

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

M-TEER

Patients with primary mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.

Primary outcome measure

  • All-cause mortality [ Time Frame: 12 months ]
  • Cardiovascular mortality [ Time Frame: 12 months ]
  • Rehospitalization for congestive heart failure [ Time Frame: 12 months ]
  • Re-do mitral valve procedure [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Benedikt Koell, MD

+4915222815230b.koell@uke.de

Sebastian Ludwig, MD

+491522816168se.ludwig@uke.de

Locations

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

More Information

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Last update posted

Apr 18, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf on 2022-04-18.