NCT03225612 - Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 22, 2017

Primary Completion Date

June 30, 2018

Study Completion Date

November 30, 2022

Conditions

Chronic Symptomatic Functional Tricuspid RegurgitationTricuspid Valve InsufficiencyHeart Valve Disease

Interventions

DEVICE

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus.

Trial Locations (11)

10967

RECRUITING

Vivantes Klinikum Am Urban, Berlin

16321

RECRUITING

Herzzentrum Brandenburg in Bernau, Bernau bei Berlin

20132

RECRUITING

Ospedale San Raffaele, Milan

22527

RECRUITING

Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH, Hamburg

56126

RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

60389

RECRUITING

CardioVascular Center Frankfurt, Frankfurt

80636

RECRUITING

German Heart Center Munich, Munich

04289

RECRUITING

Herzzentrum Leipzig - Universitätsklinik, Leipzig

4818 CK

NOT_YET_RECRUITING

Amphia Ziekenhuis, Breda

9713 GZ

RECRUITING

University Medical Center Groningen, Groningen

Unknown

RECRUITING

C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E., Porto