Purpose

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • clinically significant mitral insufficiency - patient underwent screening for TMVI - echocardiography data at baseline (and after TMVI, E2E and surgery) - follow-up of at least 30 days

Exclusion Criteria

  • age under 18 years

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Transcatheter Mitral Valve Implantation (TMVI) Patients with successful TMVI screening, who underwent Transcatheter Mitral Valve Implantation subsequently. All devices may be included.
Interventional mitral valve edge-to-edge repair (E2E) Patients with TMVI screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair.
Mitral valve surgery (Surgery) Patients with TMVI screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement).
Medical therapy (OMT) Patients with TMVI screening failure, who subsequently underwent conservative or optimal medical therapy (OMT).

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Tsuyoshi Kaneko, MD

More Details

Status
Recruiting
Sponsor
Universitätsklinikum Hamburg-Eppendorf

Study Contact

Sebastian Ludwig, MD
+4915222816168
se.ludwig@uke.de

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.