NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study

NCT03929913 | Completed Results FDA Device

• 2 other identifiers: 19008819-H-0088
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Functional Mitral Regurgitation

Keywords

Ventricular Dysfunction; Functional Mitral Regurgitation; Heart Failure; Mitral Implant; Secondary Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is Technical Success

  The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present: 1. Alive 2. Successful deployment and correct positioning of a single intended Transcatheter Mitral Cerclage Annuloplasty (TMCA). Repositioning and recapture of the device, if needed, is not classified as failure. 3. Retrieval of the TMCA delivery system 4. Absence of TMCA-related coronary artery compression and absence of additional procedure such as percutaneous coronary intervention (PCI) to relieve coronary artery compression. 5. No additional unplanned or emergency surgery or re-intervention related to the TMCA or delivery system.

  1 minute following procedure discharge (Exit from the catheterization laboratory)

Secondary Outcomes (1)

• The Secondary Endpoint is Procedural Success

  Day 30 post procedure

Study Arms (1)

Transcatheter Mitral Valve Cerclage Annuloplasty

EXPERIMENTAL

To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve regurgitation despite optimal medical therapy. The TMCA 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)

Interventions

Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) DEVICE

The Transcatheter Mitral Cerclage Annuloplasty implant has two components, with or without a coronary artery protection element, and the wishbone lock with coronary sinus and right ventricular outflow track limbs. Procedure is performed from a trans-jugular venous approach. Coronary guidewires and microcatheters are used to navigate into a coronary vein to 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 the coronary protection element lies directly over any underlying branch of the left coronary artery. The wishbone lock is 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. After desired tension has been achieved, the wishbone lock is locked and the two limbs of the implant are cut with a cutter catheter.

Transcatheter Mitral Valve Cerclage Annuloplasty

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (3)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322-1102, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Ventricular Dysfunction; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Robert Lederman, Principal Investigator
• Organization: National Heart, Lung, and Blood Institute (NHLBI)

ledermar@nhlbi.nih.gov

301.402.6769

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 29, 2019
• Study Start: May 7, 2019
• Primary Completion: February 23, 2021
• Study Completion: February 27, 2026
• Last Updated: April 29, 2026
• Results First Posted: March 8, 2023

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)