NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

May 7, 2019

Primary Completion Date

February 23, 2021

Study Completion Date

December 31, 2025

Conditions
Functional Mitral Regurgitation
Interventions
DEVICE

Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)

The Transcatheter Mitral Cerclage Annuloplasty implant has two components, with or without a coronary artery protection element, and the wishbone lock with coronary sinus and right ventricular outflow track limbs. Procedure is performed from a trans-jugular venous approach. Coronary guidewires and microcatheters are used to navigate into a coronary vein to the target capture catheter. The implant is then attached to the back end of the guidewire and pulled out of the internal jugular sheath. The position of the implant is adjusted so the coronary protection element lies directly over any underlying branch of the left coronary artery. The wishbone lock is advanced over the two limbs of the implant and the desired tension is titrated to the degree of mitral regurgitation. Coronary angiography is performed to confirm there is no coronary compression. After desired tension has been achieved, the wishbone lock is locked and the two limbs of the implant are cut with a cutter catheter.

Trial Locations (3)

20010

MedStar Washington Hospital Center, Washington D.C.

24014

Carilion Medical Center, Roanoke

30322-1102

Emory University, Atlanta

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT03929913 - NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study | Biotech Hunter | Biotech Hunter