TMCA for Mitral Regurgitation

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Inability to consent, Pregnancy, TAVR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

19 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on optimal medical therapy for at least one month before participating.

What data supports the effectiveness of the treatment Transcatheter Mitral Cerclage Annuloplasty for Mitral Regurgitation?

Research shows that mitral annuloplasty, a similar treatment, has been effective in reducing symptoms and improving heart function in patients with severe mitral regurgitation. In one study, 70% of patients experienced symptom improvement and better heart function after undergoing annuloplasty. ^{1 2 3 4 5}

Is Transcatheter Mitral Cerclage Annuloplasty (TMCA) safe for humans?

The MitraClip, a similar transcatheter mitral valve repair device, has been shown to be safe for patients with severe mitral regurgitation, especially those at high risk for surgery. Studies have reported that it provides a safe means of valve repair, with data from large registries supporting its safety profile. ^{6 7 8 9 10}

How is the treatment Transcatheter Mitral Cerclage Annuloplasty (TMCA) unique for mitral regurgitation?

Transcatheter Mitral Cerclage Annuloplasty (TMCA) is unique because it offers a minimally invasive way to treat mitral regurgitation by reshaping the mitral valve's structure without open-heart surgery. This approach is particularly beneficial for patients who are at high risk for traditional surgery, providing a safer alternative with potentially quicker recovery times. ^{3 4 11 12 13}

What is the purpose of this trial?

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.

Research Team

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

This trial is for adults over 21 with functional mitral valve regurgitation, a heart condition causing leakage and failure. Participants must have symptoms like breathlessness or fluid buildup, be on stable heart medication for at least a month, and have specific heart function levels. Those who've had certain previous treatments like MitraClip can join if it's been over 30 days.

Inclusion Criteria

Your heart's pumping function, as measured by echocardiography, CT, or CMR, is at least 20%.

I have been on the best treatment for my condition for at least a month.

I have symptoms from a leaking mitral valve in my heart.

Exclusion Criteria

Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures

If you have a MitraClip that has come loose.

I have moderate to severe aortic stenosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Transcatheter Mitral Cerclage Annuloplasty procedure to treat mitral valve regurgitation

1 day

1 visit (in-person, catheterization laboratory)

Immediate Follow-up

Participants are monitored for technical success immediately after the procedure

1 minute following procedure discharge

Follow-up

Participants are monitored for procedural success and adverse events

30 days

1 visit (in-person)

Treatment Details

Interventions

• Transcatheter Mitral Cerclage Annuloplasty

Trial Overview The study tests a new catheter-based technique called Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat mitral valve leakage without surgery. It involves implanting devices that tighten around the valve to prevent leakage while protecting coronary arteries from being squeezed.

Participant Groups

Group I: Transcatheter Mitral Valve Cerclage Annuloplasty Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Findings from Research

Transcatheter mitral valve repair (TMVR) using the MitraClip system was successfully performed on 3 Chinese patients with severe mitral regurgitation, showing significant improvements in heart function and pressure measurements post-procedure.

All patients experienced a reduction in heart chamber sizes and NT-ProBNP levels, indicating improved heart function, with no complications reported, suggesting that TMVR is a safe and effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Initial experience of treating patients with severe mitral regurgitation with transcatheter mitral valve edge-to-edge repair in China]. Ge, JB., Zhou, DX., Pan, WZ., et al.[2013]

The MitraClip procedure was successfully performed on 115 high-risk patients with a low 30-day mortality rate of 2.6%, demonstrating its safety as a treatment for mitral valve regurgitation.

Patients experienced significant improvements in their condition, with 80.7% showing reduced mitral regurgitation at discharge and 81% reporting better functional status one month after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state of transcatheter mitral valve repair with the MitraClip. Downs, EA., Lim, DS., Saji, M., et al.[2020]

Transcatheter mitral valve repair (TMVR) is a safer option than surgical mitral valve repair (SMVR) for older patients and those with more comorbidities, showing lower rates of complications such as permanent pacemaker implantation and major bleeding.

Despite being older and having higher comorbidity scores, TMVR patients experienced shorter hospital stays and were less likely to be discharged to skilled nursing facilities compared to those undergoing SMVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes. Jogu, HR., Arora, S., Strassle, PD., et al.[2021]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Mitral valve replacement versus annuloplasty for treating severe functional mitral regurgitation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation: First Human Results. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Transcatheter mitral direct annuloplasty: state of the art. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Improvement following correction of secondary mitral regurgitation in end-stage cardiomyopathy with mitral annuloplasty. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[Initial experience of treating patients with severe mitral regurgitation with transcatheter mitral valve edge-to-edge repair in China]. [2013]

7. China pubmed.ncbi.nlm.nih.gov

Current state of transcatheter mitral valve repair with the MitraClip. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Reasons for Screen Failure for Transcatheter Mitral Valve Repair and Replacement. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of age and comorbidities on the effect of transcatheter versus surgical mitral valve repair on inpatient outcomes. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry. [2016]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter, Transapical Mitral Valve Replacement After Mitral Valve Annuloplasty. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. [2016]

13. Australia pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Repair-Beyond the EVEREST and COAPT Criteria. [2023]