TMCA for Mitral Regurgitation

Not currently recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called transcatheter mitral cerclage annuloplasty for treating functional mitral valve regurgitation. This condition occurs when the heart’s mitral valve leaks, leading to heart failure symptoms like breathlessness and fatigue. The trial aims to determine if this technique, which uses a special device to tighten the valve without surgery, is safe and effective. Individuals with heart failure symptoms due to mitral valve leakage, even after Mitra-Clip treatment, might be suitable candidates for this trial. As an unphased trial, it offers patients the opportunity to explore an innovative treatment option that could improve their quality of life.

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 prior data suggests that this technique and devices are safe for treating mitral regurgitation?

Research has shown that Transcatheter Mitral Cerclage Annuloplasty (TMCA) demonstrates promising safety results. Earlier studies found no deaths, strokes, or major heart problems during the procedure, suggesting TMCA is generally safe for patients. TMCA uses a special device to tighten the mitral valve, reducing leakage and improving heart function. The device avoids pressing on a nearby artery, enhancing safety. While these findings are reassuring, it is important to note that this is an early study, and further research is needed to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcatheter Mitral Cerclage Annuloplasty (TMCA) because it offers a new, minimally invasive approach to treating mitral regurgitation in patients with heart failure. Unlike traditional surgical options, such as open-heart surgery or mitral valve repair, TMCA is performed using a catheter-based technique that involves threading a device through the veins to reshape the mitral valve. This approach potentially reduces recovery time and surgical risk, making it an attractive option for patients who are not candidates for surgery. Additionally, TMCA directly addresses the structural issues of the mitral valve, offering a targeted solution that could improve patient outcomes.

What evidence suggests that this technique and devices are effective for mitral valve regurgitation?

Studies have shown that Transcatheter Mitral Cerclage Annuloplasty (TMCA), the treatment under evaluation in this trial, can significantly improve a leaky mitral valve. Research indicates that TMCA also enhances daily life for people with heart failure. Many patients have successfully received a permanent device through this treatment. Early findings suggest that this procedure reduces mitral valve leakage, often responsible for heart failure symptoms. Although the results are promising, researchers continue to study this new treatment to understand its full benefits. ^{1 5 6 7 8}

Who Is on the Research Team?

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9236160/

Transcatheter Mitral Cerclage Ventriculoplasty Conclusions: Transcatheter Mitral Cerclage Ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation, and in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879822008305

Transcatheter Mitral Cerclage Ventriculoplasty Transcatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation and in heart failure quality-of-life ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3034128/

Mitral cerclage annuloplasty, a novel transcatheter treatment ... In the third phase in 16 consecutive swine with ischemic cardiomyopathy, cerclage was successful in 14 (88%). Both failures were nonfatal exit (perforation) ...

4. annalscts.com annalscts.com/article/view/16780/17292

the advancement of transcatheter mitral valve repair - Denti Fifty-three patients were enrolled, and results reported successful permanent device implantation in 36 patients. Furthermore, there was evidence of significant ...

5. jacc.org jacc.org/doi/10.1016/j.jcin.2016.12.282

Mitral Loop Cerclage Annuloplasty for Secondary ... Mitral loop cerclage was successful in 4 of 5 subjects and aborted in 1 of the 5 because of unsuitable septal coronary vein anatomy. Immediately ...

6. jacc.org jacc.org/doi/10.1016/j.jcin.2022.04.013

Transcatheter Mitral Cerclage Ventriculoplasty There were no procedural deaths, strokes, or transient ischemic attacks or other major cardiovascular adverse events. The primary endpoint was ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03929913

NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty ... To evaluate the feasibility and safety of Transcatheter Mitral Cerclage Annuloplasty (TMCA) to treat symptomatic heart failure accompanied by mitral valve ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0735109709017318

Mitral Cerclage Annuloplasty, A Novel Transcatheter ... We developed and tested a novel transcatheter circumferential annuloplasty technique to reduce mitral regurgitation in porcine ischemic cardiomyopathy.