19
Participants
Start Date
May 7, 2019
Primary Completion Date
February 23, 2021
Study Completion Date
December 31, 2025
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.
MedStar Washington Hospital Center, Washington D.C.
Carilion Medical Center, Roanoke
Emory University, Atlanta
National Heart, Lung, and Blood Institute (NHLBI)
NIH