NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
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|ClinicalTrials.gov Identifier: NCT03929913|
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2019
Last Update Posted : March 10, 2021
This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation, called transcatheter mitral valve cerclage annuloplasty, otherwise known as cerclage. Functional mitral valve regurgitation is a condition caused by damaged heart muscle involving the left ventricle which results in mitral valve leakage. This leakage causes heart failure (breathlessness and lack of energy especially when walking or exercising, and hospital admissions for fluid buildup).
This is an early feasibility study (EFS) evaluation of special devices, permanently implanted in the heart, to perform mitral cerclage annuloplasty. Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery. The cerclage devices compress the mitral valve like a purse-string. The cerclage device has a special feature that prevents a coronary artery from getting squeezed as part of this purse-string.
The protocol has been changed to allow patients who have mitral valve regurgitation despite prior Mitra-Clip treatment, and to allow patients who have symptomatic heart failure with mild mitral regurgitation....
|Condition or disease||Intervention/treatment||Phase|
|Functional Mitral Regurgitation and Symptomatic Heart Failure||Device: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty(TMCA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study|
|Actual Study Start Date :||May 7, 2019|
|Estimated Primary Completion Date :||January 30, 2022|
|Estimated Study Completion Date :||December 31, 2026|
Experimental: Study Arm #1
The Transcatheter Mitral Cerclage Annuloplasty implant is attached to a guidewire and pulled through the internal jugular sheath, along the coronary sinus, through the basal septum, through the tricuspid valve, and back out of the internal jugular sheath. The position of the TMCA implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery.
Device: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty(TMCA)
The Transcatheter Mitral Cerclage Annuloplasty implant comprises two components, with or without a coronary artery protection element, and the wishbone lock with coronary sinus and RVOT limbs. The procedure is performed from a transjugular venous approach. Coronary guidewires and microcatheters are used to navigate into a coronary vein towards 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 that the coronary protection element lies directly over any underlying branch of the left coronary artery. The wishbone lock is then 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. Once the desired tension has been achieved, the wishbone lock is locked and the two limbs of the implant are cut with a cutter catheter.
- The primary endpoint is technical success measured at exit from the catheterization laboratory. [ Time Frame: Exit from the catheterization laboratory ]The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present:-Alive-Successful deployment and correct positioning of a single intended Transcatheter Mitral Cer-clage Annuloplasty (TMCA). Repositioning and recapture of the device, if needed, is not classified as failure.-Retrieval of the TMCA delivery system-Absence of TMCA-related coronary artery compression and absence of additional procedure such as percutaneous coronary intervention (PCI) to relieve coronary artery compression-No additional unplanned or emergency surgery or re- intervention related to the TMCA or de-livery system
- The secondary endpoint is Procedural success [ Time Frame: Measured at 30 day post procedure ]The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present-Technical success-No TMCA device-related Serious Adverse Events, defined as VARC-2 life- threatening bleeding, major vascular or cardiac complications related to the TMCA requiring unplanned reintervention or surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929913
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322-1102|
|United States, Virginia|
|Carilion Medical Center|
|Roanoke, Virginia, United States, 24014|
|Principal Investigator:||Robert J Lederman, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|