An interventional study of Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) in Functional Mitral Regurgitation, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 3 sites in United States. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 19 is below the median of 60 across 49 interventional studies indexed under Ventricular Dysfunction.
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Adults age >=21 years
Symptomatic functional mitral valve regurgitation
EXCLUSION CRITERIA:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
Time frame: 1 minute following procedure discharge (Exit from the catheterization laboratory)
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: 1. Technical success 2. 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.
Time frame: Day 30 post procedure
Nineteen subjects consented and underwent cerclage procedures between May 2019 and February 2021, despite COVID-19-related delays.
| Milestone | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| Started | 19 |
| Completed | 12 |
| Not completed | 7 |
| Withdrew: Death | 4 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Failed procedure | 2 |
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.
| Participants | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| The Primary Endpoint is Technical Success | 17 |
The secondary endpoint is Procedural success This endpoint is measured at 30 days. All of the following must be present: 1. Technical success 2. 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.
| Participants | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| The Secondary Endpoint is Procedural Success | 16 |
Collected over 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transcatheter Mitral Valve Cerclage Annuloplasty | 5/19 (26.3%) | 12/19 (63.2%) | 19/19 (100%) |
| Event | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| Heart failureCardiac disorders | 7/19 |
| Atrioventricular block completeCardiac disorders | 4/19 |
| HypotensionVascular disorders | 3/19 |
| Acute kidney injuryRenal and urinary disorders | 2/19 |
| Atrial fibrillationCardiac disorders | 2/19 |
| EncephalopathyNervous system disorders | 2/19 |
| Abdominal painGastrointestinal disorders | 1/19 |
| AnemiaBlood and lymphatic system disorders | 1/19 |
| Cardiac arrestCardiac disorders | 1/19 |
| Cardiogenic Shock-post cardiac arrestCardiac disorders | 1/19 |
| Event | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| Cardiac troponin I increasedCardiac disorders | 19/19 |
| Cardiac troponin I increasedInvestigations | 19/19 |
| LeukocytosisBlood and lymphatic system disorders | 13/19 |
| AnemiaBlood and lymphatic system disorders | 9/19 |
| Platelet count decreasedInvestigations | 8/19 |
| Heart failureCardiac disorders | 6/19 |
| Conduction disorderCardiac disorders | 5/19 |
| Creatinine increasedInvestigations | 5/19 |
| BNP elevated post procedureInvestigations | 5/19 |
| NT-BNP elevated post procedureInvestigations | 4/19 |
| Age, Categorical(Participants) | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 14 |
| Sex: Female, Male(Participants) | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| Female | 12 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| United States | 19 |
| Heart failure with reduced ejection fraction (HFrEF)(Participants) | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| Count of participants | 12 |
| Heart failure with preserved ejection fraction (HFpEF)(Participants) | Transcatheter Mitral Valve Cerclage Annuloplasty |
|---|---|
| Count of participants | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The authors are willing to share de-identified subject data upon reasonable request.
Ran from May 2019 to primary completion in Feb 2021, 21 months.
Results were first posted in Mar 2023, 2 years after primary completion. A results delay was requested in Jan 2023.
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