PRIMARY


Study information
PRIMARY

Recruiting status

Recruiting ongoing

Recruitment start

03/2023

Patients

13

113

Clinical Trials Registration

NCT05051033

Category

Guideline relevant study

DZHK Funding

EUR 1.364.596

Operative contact
Andreas Bader-Wölfle, MD
andreas.bader-woelfle@dhzc-charite.de

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for >60 Year-olds (PRIMARY)

The PRIMARY study investigates whether a surgical or catheter-based approach is better for repairing mitral valve prolapse. The PRIMARY study will enroll patients 60 years and older with severe mitral regurgitation due to mitral valve prolapse. Patients will be randomly divided into two groups. One-half will be treated surgically - usually endoscopically. The other group will be treated by catheter procedures.

The study team will check whether the patients are alive and healthy three years after treatment or need to be hospitalized again because of the mitral valve or heart failure. Patients will get a follow-up ten years after treatment. Of course, the outcome of the repair will also be reviewed. The study offers a unique opportunity to follow which method is better in the long term.

Prof. Volkmar Falk of the German Heart Center at Charité is leading the German arm of the U.S. PRIMARY study. In addition to the DHZC, 16 other German centers will participate in the study. A total of 113 study participants are to be included.

Publications

There are no publications available yet.

Principal Investigators

Principal investigator for Germany: Volkmar Falk (Berlin), PI (Sponsor): Annetine C. Gelijns (Icahn School of Medicine at Mount Sinai, NY, USA), Co-PI for Germany: Stefan Blankenberg (Hamburg), Michael Borger (Leipzig)

Press releases and news

Mitral valve repair: Surgery or interventional treatment? (PRIMARY trial)

A leaking mitral valve can be repaired surgically or with catheter-based techniques. A so-called...