TMVr System for Mitral Valve Regurgitation

Recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Half Moon TMVr System (Transcatheter Mitral Valve Repair System) to evaluate its safety and effectiveness for individuals with severe mitral valve issues causing symptoms like shortness of breath or fatigue. It targets those who cannot undergo regular surgery due to high risks. Participants should have significant mitral valve leakage and experience symptoms despite adhering to medical advice. As an unphased trial, this study provides patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that the Half Moon TMVr System is safe for treating mitral valve regurgitation?

The Half Moon TMVr System is under testing to assist individuals with severe mitral valve regurgitation, a heart condition where blood flows backward. This system aims to repair the valve without major surgery, offering a significant advantage for those at high risk with traditional surgery.

Researchers are still studying the safety of this system, but early results are promising. In a small study involving 15 patients, the device was used without major issues, suggesting potential safety. However, further research is necessary to confirm this.

As an Early Feasibility Study, it may not provide as much safety information as later studies. Researchers continue to learn about the device's safety. Participants should remember that while early results are encouraging, more tests are needed to fully understand the safety of the Half Moon TMVr System. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Half Moon TMVr System because it offers a minimally invasive option for treating mitral valve regurgitation. Unlike traditional open-heart surgery, this system is designed for transfemoral access, which means it can be delivered through a vein in the leg, making the procedure less invasive and potentially reducing recovery time. Additionally, the Half Moon TMVr System utilizes a self-expanding implant to restore the heart valve's function, which could provide a more precise and effective repair. These features present a significant advancement over current surgical methods, promising to make treatment easier and less taxing for patients.

What evidence suggests that the Half Moon TMVr System is effective for mitral valve regurgitation?

Research has shown that the Half Moon TMVr System, which participants in this trial will receive, might effectively treat severe mitral regurgitation, a condition where the heart's mitral valve doesn't close properly. In a small study, 15 patients received this device, and the results were promising. The Half Moon system is designed to repair the mitral valve without open-heart surgery, using a less invasive method. This approach could lead to shorter hospital stays and similar survival rates compared to traditional surgery. It is intended for patients at high risk for regular surgery, offering a new option for those needing mitral valve repair. While more research is needed, early results suggest this system could be a valuable treatment choice. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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 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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04343313

NCT04343313 | The Half Moon Transcatheter Mitral Valve ... 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 ...

2. citoday.com citoday.com/news/half-moon-medicals-pilot-study-of-tmvr-system-continues-enrollment

Half Moon Medical's Pilot Study of TMVR System ... Half Moon Medical announced the treatment of 15 patients with the second-generation Half Moon transcatheter mitral valve repair (TMVR) device.

3. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/1554/evaluation-safety-performance-half/

The Half Moon TMVr Pilot Study - Clinical Trials 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 ...

4. recruit.cumc.columbia.edu recruit.cumc.columbia.edu/studyinfopage/2056

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Study The TMVR System provides the same treatment as that of the standard valve implant used during conventional mitral repair but using a less invasive approach.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7262433/

Outcomes of open mitral valve replacement versus ... Patients undergoing TMVR were older and more financially affluent. TMVR was more costly but was associated with a shorter hospital stay and similar mortality ...

6. cms.gov cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved/g200185-1-nct04343313

G200185-1-NCT04343313 Evaluation of the safety and performance of the half moon transcatheter mitral valve repair system in high risk patients with severe, symptomatic mitral ...