Functional Mitral RegurgitationNCT03929913
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
A study testing Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) in people with Functional Mitral Regurgitation, run by National Heart, Lung, and Blood Institute (NHLBI) at 3 sites in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 May 2019to 27 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322-1102
Carilion Medical Center
Roanoke, Virginia, 24014
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
- Keywords
- Ventricular Dysfunction, Functional Mitral Regurgitation, Heart Failure, Mitral Implant, Secondary Mitral Regurgitation
- Medical subject headings
- Ventricular Dysfunction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Alive
- 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.
- Retrieval of the TMCA delivery system
- Absence of TMCA-related coronary artery compression and absence of additional procedure such as percutaneous coronary intervention (PCI) to relieve coronary artery compression.
- No additional unplanned or emergency surgery or re-intervention related to the TMCA or delivery system.
Measured: 1 minute following procedure discharge (Exit from the catheterization laboratory)
Secondary outcomes (1)
The Secondary Endpoint is Procedural Success
The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present:
- Technical success
- No Transcatheter Mitral Cerclage Annuloplasty (TMCA) device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TMCA requiring unplanned reintervention or surgery.
Measured: Day 30 post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start7 May 2019
- Primary completion23 Feb 2021
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929913
- Sponsor's protocol ID
- 190088
- Other IDs
- 19-H-0088
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2019
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The authors are willing to share de-identified subject data upon reasonable request.