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CTSN-TVR-DZHK14

Evaluating the benefit of concurrent tricuspid valve repair during mitral surgery (CTSN-TVR-DZHK14)

Insufficiency (leakage) of the mitral valve in the left side of the heart can also lead to tricuspid valve insufficiency in the right side of the heart. The guidelines state that severe tricuspid valve insufficiency should also be treated during the mitral valve correction or replacement surgery; however, there is uncertainty regarding whether it should be operated on if it is only mildly or moderately impaired. Reliable data is not yet available.

The new study “CTSN-TVR-DZHK14” is aiming to clarify whether it is better to operate on both valves concurrently, even if the tricuspid valve does not yet leak much. The guidelines for this patient group could then also be refined.

The study will be conducted by the DZHK together with the US “Cardiothoracic Surgical Trials Network (CTSN)”. Prof. Dr. med. Volkmar Falk, Medical Director of the German Heart Center Berlin and Director of the Department of Cardiovascular Surgery at Charité - Universitätsmedizin Berlin, heads the study on the German side. 400 patients shall be included. In Germany, a total of 16 centres are participating in the study – 9 of which are DZHK centres. In the USA and Canada there are 20 participating centres.

Principal Investigators

Principal investigator for Germany: Volkmar Falk (Berlin), PI (Sponsor): Annetine C. Gelijns (Icahn School of Medicine at Mount Sinai, NY, USA)

Medical institution

Deutsches Herzzentrum Berlin (DHZB) / Icahn School of Medicine at Mount Sinai

Keywords

Recruitment start

06/2017

Patients (planned)

76 (Germany)

Patients (recruited)

76 (completed)

ClinicalTrials.gov

NCT02675244