NCT03929913Completed
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 26 Apr 2019
- Start date
- 7 May 2019
- Primary completion date
- 23 Feb 2021
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Diseases
- Heart failure
- NCT number
- NCT03929913
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 7 May 2019 to the primary completion date, 23 Feb 2021
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Other
- Subjects unable to consent to participate
- Subjects unwilling to participate or unwilling to return for study follow-up activities.
- TAVR within 6 weeks
- Aortic stenosis more than mild in severity
- Single-leaflet MitraClip detachment, if present
Criteria the registry did not label
- INCLUSION CRITERIA:
- Adults age \>=21 years
- Symptomatic functional mitral valve regurgitation
- Mild or greater mitral valve regurgitation, LVEF \<= 0.50, and NYHA class III - IV heart failure
- Moderate or greater mitral valve regurgitation and NYHA II - IV heart failure, irrespective of LV systolic function
- On optimal medical therapy for at least one month
- Left ventricular ejection fraction \>=0.20 assessed by echocardiography, CT, or CMR
- Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on pre-procedural cardiac CT or coronary venogram
- Concordance of the Study Eligibility Committee
- If present, a MitraClip was implanted at least 30 days previously
Age in the registry: 21 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Carilion Medical Center Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.