TMVr System for Mitral Valve Regurgitation

Recruiting at 4 trial locations

Overseen By Romil Rambhia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Half Moon Medical

Disqualifiers: Prior stroke, COPD, Renal insufficiency, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 30 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be on guideline-directed medical therapy for mitral regurgitation and be willing to follow the recommended anticoagulation treatment.

What data supports the effectiveness of the Half Moon TMVr System treatment for Mitral Valve Regurgitation?

The Half Moon TMVr System is a type of transcatheter mitral valve repair (TMVR), which has been shown to be a feasible option for patients with severe mitral regurgitation who are at high risk for surgery. Early experiences with TMVR, including similar devices, have demonstrated its potential to reduce mitral regurgitation effectively, although more studies are needed to confirm its long-term safety and effectiveness. ^{1 2 3 4 5}

Is the TMVr System for Mitral Valve Regurgitation safe for humans?

Transcatheter mitral valve repair (TMVR) has been shown to be a safe treatment option for patients with severe mitral regurgitation, especially those who are at high risk for surgery. Early clinical experiences with TMVR systems have demonstrated feasibility and safety, but more studies with larger patient groups are needed to confirm these findings. ^{1 2 3 6 7}

How is the Half Moon TMVr System treatment different from other treatments for mitral valve regurgitation?

The Half Moon TMVr System is a minimally invasive treatment for mitral valve regurgitation, using a catheter to repair the valve without the need for open-heart surgery. This approach can lead to better outcomes, shorter hospital stays, and lower mortality rates compared to traditional surgical methods. ^{1 2 4 5 8}

Eligibility Criteria

This trial is for adults over 21 with severe, symptomatic mitral valve regurgitation who are at high risk for conventional surgery. Candidates must have a compatible native mitral valve geometry and size, suitable anatomy for the device access route, and be on guideline-directed medical therapy. Exclusions include recent heart attacks or strokes, certain heart failures or surgeries, renal insufficiency, bleeding disorders, pregnancy, and some other specific health conditions.

Inclusion Criteria

My heart can be accessed through my leg for a valve repair procedure.

My heart team considers me high risk for mitral valve surgery and unsuitable for other valve treatments.

I am 21 years old or older.

Exclusion Criteria

I have severe leakage in my heart's tricuspid valve.

My heart's mitral valve has a problem like flail or prolapse.

I am not pregnant, nursing, or planning to become pregnant and have a negative pregnancy test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Half Moon TMVr System implant via transfemoral access and transseptal delivery

30 days

1 visit (in-person)

Follow-up

Participants are monitored for safety, device performance, and symptom improvement

5 years

Annual visits (in-person)

Treatment Details

Interventions

• Half Moon TMVr System

Trial Overview The Half Moon TMVr System is being tested in this early feasibility study to see if it's safe and works well for people with severe mitral regurgitation who can't have standard surgery. It's a single-arm study where all participants receive the new treatment through transfemoral transseptal access without being compared to another group.

Participant Groups

Group I: Half Moon TMVr System Experimental Treatment 1 Intervention

The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.

Half Moon TMVr System is already approved in United States for the following indications:

Approved in United States as Half Moon TMVr System for:

• Severe, symptomatic mitral regurgitation

Who Is Running the Clinical Trial?

Half Moon Medical

Lead Sponsor

Trials

1

Recruited

30+

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]

In a study of 95 transcatheter mitral valve repair (TMVR) procedures, higher hospital volumes were linked to significantly lower rates of in-hospital mortality and complications, with rates dropping from 48.7% in low-volume hospitals to just 9.1% in high-volume hospitals.

Patients at high-volume hospitals also experienced shorter hospital stays and potentially lower hospitalization costs, suggesting that choosing a facility with more TMVR experience may improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Hospital Volume on Outcomes of Transcatheter Mitral Valve Repair: An Early US Experience. Patel, NJ., Badheka, AO., Jhamnani, S., et al.[2019]

Transcatheter mitral valve replacement (TMVR) is a promising new option for treating severe primary mitral regurgitation (MR) in patients at high surgical risk, showing feasibility in early trials with over 100 patients.

TMVR may provide more effective and consistent reduction of MR compared to traditional transcatheter mitral valve repair methods, but further studies with larger patient groups are necessary to establish safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges. Regueiro, A., Granada, JF., Dagenais, F., et al.[2020]

In a study of five high-risk patients undergoing transcatheter mitral valve replacement (TMVR) with the Tendyne device, most patients showed significant improvement in symptoms and exercise capacity after 18 months to two years, indicating the device's efficacy.

Despite some complications, the Tendyne device demonstrated stability and good hemodynamic function, with no new paravalvular leaks or late migration observed in surviving patients, suggesting a favorable safety profile for this novel treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement: long-term outcomes of first-in-man experience with an apically tethered device- a case series from a single centre. Duncan, A., Daqa, A., Yeh, J., et al.[2022]

Transcatheter mitral valve replacement (TMVR) is a new treatment for severe mitral regurgitation, but it currently has a high 30-day mortality rate exceeding 30%, indicating significant risks associated with the procedure.

Despite its challenges, TMVR has shown promise in treating patients with degenerative mitral stenosis and failed mitral repairs, leading to ongoing multicenter registries aimed at improving device design and understanding the procedure's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. Sarkar, K., Reardon, MJ., Little, SH., et al.[2019]

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]

The Edwards PASCAL TMVr system demonstrated a high technical success rate of 96% in treating severe mitral regurgitation in a cohort of 23 high-risk patients, with significant reduction in regurgitation severity after the procedure.

At 30 days post-implantation, 78% of patients achieved device success, and 95% of those alive reported improved heart function, indicating the system's efficacy despite the complexity of their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study. Praz, F., Spargias, K., Chrissoheris, M., et al.[2018]

Transcatheter mitral valve repair and replacement (TMVR) offers a minimally invasive and safer alternative to traditional open-heart surgery for patients with mitral valve regurgitation, leading to better clinical outcomes.

TMVR has been associated with shorter hospital stays and lower mortality rates, highlighting its potential benefits, especially in regions like South Asia where heart-related complications are prevalent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement: An Alternate Treatment Methodology for Patients at High Surgical Risk. Jawed, S., Zubair, U., Zubair, Z.[2020]

References

1. 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]

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

Effect of Hospital Volume on Outcomes of Transcatheter Mitral Valve Repair: An Early US Experience. [2019]

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

Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement: long-term outcomes of first-in-man experience with an apically tethered device- a case series from a single centre. [2022]

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

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. [2019]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study. [2018]

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

Transcatheter Mitral Valve Replacement: An Alternate Treatment Methodology for Patients at High Surgical Risk. [2020]