Clinical trial NCT03929913: NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Official title: NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Functional Mitral Regurgitation
Keywords: Ventricular Dysfunction
Functional Mitral Regurgitation
Heart Failure
Mitral Implant
Secondary Mitral Regurgitation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-04-29
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Functional mitral regurgitation (also known as secondary mitral regurgitation) is a common complication of left ventricular dysfunction. Ventricular dysfunction leads to dilation, which in turn leads to mitral annular dilation and leaflet traction. This causes a failure of coaptation of the otherwise intact leaflets of the mitral valve, leading to regurgitation through a central orifice between the mal-coapting leaflet tips. Functional mitral regurgitation contributes to heart failure symptoms. Transcatheter Mitral Cerclage Annuloplasty (TMCA) is a new catheter technique that reduces the septal-lateral dimension of the dilated annulus through circumferential compression, prevents extrinsic compression and entrapment of coronary arteries by incorporating a protection element, and exhibits planar discordance that achieves annular reduction even when the coronary sinus is anatomically located along the posterior left atrial wall. This is an entirely right-sided procedure and device.

Eligibility criteria: * INCLUSION CRITERIA:

  1. Adults age \>=21 years
  2. Symptomatic functional mitral valve regurgitation

     1. Mild or greater mitral valve regurgitation, LVEF \<= 0.50, and NYHA class III - IV heart failure
     2. 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

Primary outcomes:
measure: The Primary Endpoint is Technical Success
timeFrame: 1 minute following procedure discharge (Exit from the catheterization laboratory)
Secondary outcomes:
measure: The Secondary Endpoint is Procedural Success
timeFrame: Day 30 post procedure
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Robert J Lederman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: