NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Completed · Not applicable
Conditions studied: Functional Mitral Regurgitation
In brief
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.
Key facts
- Study ID
- NCT03929913
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 19
- Starts
- 2019-05-07
- Expected to finish
- 2026-02-27
- Last updated by the study team
- 2026-04-29
Who can join
Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects unable to consent to participate
- Subjects unwilling to participate or unwilling to return for study follow-up activities.
- Prior cardiac implanted electronic devices (CIED) likely to be entrapped by cerclage.
- - Candidates with coronary sinus or left ventricular pacing or defibrillation leads that are not likely to be entrapped by cerclage, evident on baseline CT or angiogram, are eligible to participate.
- TAVR within 6 weeks
- Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
- Aortic stenosis more than mild in severity
- Single-leaflet MitraClip detachment, if present
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Where it is running
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Emory University — Atlanta, Georgia, United States
- Carilion Medical Center — Roanoke, Virginia, United States
Full record on ClinicalTrials.gov
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