This study is NOT currently recruiting participants.
Number |
19-H-0088 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 21 Years
Max Age: 99 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Fetuses;
Pregnant Women;
Children |
Keywords |
Ventricular Dysfunction;
Functional Mitral Regurgitation;
Heart Failure;
Mitral Implant;
Secondary Mitral Regurgitation |
Recruitment Keyword(s) |
None |
Condition(s) |
Functional Mitral Regurgitation |
Investigational Drug(s) |
None |
Investigational Device(s) |
Transmural Systems Transcatheter Mitral Cerclage Annuloplasty Device
|
Intervention(s) |
Device: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
|
Supporting Site |
National Heart, Lung, and Blood Institute |
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.
INCLUSION CRITERIA:
1. Adults age >=21 years
2. Symptomatic functional mitral valve regurgitation
a. Mild or greater mitral valve regurgitation, LVEF <= 0.50, and NYHA class III - IV heart failure
b. Moderate or greater mitral valve regurgitation and NYHA II - IV heart failure, irrespective of LV systolic function
3. On optimal medical therapy for at least one month
4. Left ventricular ejection fraction >=0.20 assessed by echocardiography, CT, or CMR
5. Suitable coronary venous anatomy for Transcatheter Mitral Cerclage Annuloplasty based on pre-procedural cardiac CT or coronary venogram
6. Concordance of the Study Eligibility Committee
7. If present, a MitraClip was implanted at least 30 days previously
EXCLUSION CRITERIA:
1. Subjects unable to consent to participate
2. Subjects unwilling to participate or unwilling to return for study follow-up activities.
3. 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.
4. TAVR within 6 weeks
5. Intended concurrent structural heart procedure, such as aortic or tricuspid valve intervention
6. Aortic stenosis more than mild in severity
7. Single-leaflet MitraClip detachment, if present
8. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures