Innovalve Artificial Mitral Valve for Mitral Valve Regurgitation

(TWIST-EFS Trial)

Recruiting at 11 trial locations

Overseen By Dirctor Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Unsuitable anatomy, Inoperable, EF<25%

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: 4 weeks

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new artificial valve called the Innovalve MR system (also known as the Innostay TMVR System or Innovalve TMVR System) to evaluate its safety and effectiveness for people with mitral valve regurgitation. This condition occurs when the heart's mitral valve fails to close properly, causing blood to flow backward and leading to symptoms like shortness of breath and fatigue. The trial seeks participants who have noticeable symptoms, are not suitable candidates for open-heart surgery, and meet specific heart anatomy criteria. Participants will receive the Innovalve system to assess its performance. As an unphased trial, this study provides a unique opportunity for patients to access innovative treatment options that may enhance their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Innovalve MR system is safe for mitral valve regurgitation?

Research shows that the Innovalve MR system appears promising in early tests. In animal studies, researchers successfully placed the Innovalve valve in the correct position, and it sealed well, indicating potential for human use. A study with a similar system reported no patient deaths from any cause within 30 days, and 6.7% died within a year, suggesting the procedure might be relatively safe in the short term for patients with similar conditions. However, specific safety data for the Innovalve system in humans is not yet available. The trial phase is labeled "Not Applicable," indicating it is still early, and safety data is being collected. Participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach for treating mitral valve regurgitation, which often involves repairing or replacing the valve with mechanical or bioprosthetic options, the Innovalve MR system is unique because it offers a novel design specifically for mitral valve replacement. This system aims to improve how the artificial valve integrates with the heart's anatomy, potentially leading to better outcomes and fewer complications. Researchers are excited about this treatment because it could provide a more durable and effective solution, reducing the need for repeat interventions and enhancing the quality of life for patients with mitral valve regurgitation.

What evidence suggests that the Innovalve MR system is effective for mitral valve regurgitation?

Research has shown that the Innovalve MR system, which participants in this trial will receive, could be a promising treatment for mitral valve regurgitation. This condition occurs when the heart's mitral valve doesn't close properly, causing blood to flow backward. In one study, doctors successfully implanted the Innovalve system in all participants, achieving a 100% success rate during surgery. This means the device was placed correctly and functioned as expected. Additionally, the death rates at 30 days and 1 year after surgery were low, indicating the treatment is relatively safe. Early results also showed that the valve sealed effectively, helping to prevent blood from leaking. This evidence suggests that the Innovalve system could be an effective option for patients with this heart condition. ^{1 2 3 5 6}

Who Is on the Research Team?

Chet Rihal

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with severe, symptomatic mitral valve regurgitation who are at high risk for open-heart surgery. Participants must meet specific anatomical criteria and have a heart's ejection fraction (EF) of more than 25%.

Inclusion Criteria

I am considered high risk for open-heart surgery.

My body meets the specific physical requirements.

I have serious symptoms from mitral valve leakage.

Exclusion Criteria

Your heart is not pumping blood effectively.

My body's structure makes me ineligible for the procedure.

My condition cannot be treated with surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mitral valve replacement with the Innovalve MR system

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Innovalve MR system

Trial Overview The study is testing the Innovalve MR system, which is a new device designed to replace the mitral valve in the heart without needing open-heart surgery. The focus is on assessing its safety and how well it works.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

MV replacement with INNOVALVE system

Innovalve MR system is already approved in United States for the following indications:

Approved in United States as Innovalve TMVR System for:

• Symptomatic moderate-severe and severe mitral regurgitation

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Innovalve Bio Medical Ltd.

Lead Sponsor

Trials

5

Recruited

100+

Published Research Related to This Trial

The Mi-thos TMVR system was successfully implanted in all 10 high-risk patients with severe mitral regurgitation, demonstrating a 100% intraoperative success rate without any periprocedural mortality or major complications during the 30-day follow-up.

All patients showed no or trace mitral regurgitation after the procedure, indicating effective valve function, with a median mitral valve gradient of 2.0 mmHg, suggesting that the Mi-thos TMVR system is a safe and feasible option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. Yang, Y., Chen, J., Dong, L., et al.[2023]

The EVOQUE transseptal transcatheter mitral valve replacement (TMVR) system was successfully used in 14 patients with moderate to severe mitral regurgitation, achieving a technical success rate of 92.9%.

At 30 days post-procedure, 83.3% of patients had no mitral regurgitation, and 81.8% showed improved functional status, indicating that this less invasive approach may be effective for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System. Webb, J., Hensey, M., Fam, N., et al.[2021]

Transapical mitral valve replacement (TMVR) using the Tiara valve was successfully performed in 12 high-risk patients with severe mitral regurgitation and previous aortic valve replacements, demonstrating a 100% procedural success rate without any major complications.

All patients experienced immediate elimination of mitral regurgitation after the procedure, indicating that TMVR with the Tiara valve is both technically feasible and safe for this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement in Patients With Previous Aortic Valve Replacement. Cheung, A., Webb, J., Schaefer, U., et al.[2019]

In a study of 94 patients with severe functional mitral regurgitation, those with ischemic mitral regurgitation (IMR) and non-ischemic mitral regurgitation (nIMR) had similar maximum mitral annulus dimensions, indicating that both groups may be suitable for transcatheter mitral valve replacement (TMVR).

However, significant differences were observed in mid-systolic geometry, with nIMR patients showing larger mitral annulus areas and perimeters, which suggests that these differences should be considered when selecting prostheses for TMVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mitral annulus geometry between patients with ischemic and non-ischemic functional mitral regurgitation: implications for transcatheter mitral valve implantation. Aruta, P., Muraru, D., Guta, AC., et al.[2019]

Transcatheter mitral valve replacement (TMVR) is a promising new treatment for patients with severe mitral regurgitation who cannot undergo traditional surgery.

The Tendyne prosthesis used in TMVR has demonstrated effectiveness and safety in high-risk patients during short-term follow-up, making it a viable alternative for managing severe mitral valve disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement with Tendyne. Niikura, H., Gössl, M., Sorajja, P.[2020]

In a study involving three patients with severe functional mitral regurgitation (MR), the use of an atrial-only fixation transcatheter mitral valve replacement (TMVR) technology resulted in a 100% technical success rate and a significant reduction in MR.

Long-term follow-up (up to 6 months) showed sustained improvements in MR and quality of life, with no major adverse events or device-related complications, suggesting this approach may reduce the risk of left ventricular outflow tract obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology. Ninios, V., Ninios, I., Ranard, LS., et al.[2023]

In a study of 400 high-risk patients with symptomatic mitral regurgitation undergoing transcatheter mitral valve replacement (TMVR), the procedure achieved a technical success rate of 95.2% and resulted in significant improvements in heart function over 2 years.

Despite the high success rate, the 2-year all-cause mortality rate was 38.1%, with chronic obstructive pulmonary disease and other health factors identified as predictors of mortality, highlighting the need for careful patient selection and management to enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. Ludwig, S., Perrin, N., Coisne, A., et al.[2023]

Transcatheter mitral valve replacement (TMVR) using a new self-expanding valve was successfully performed in 50 high-risk patients with symptomatic severe mitral regurgitation, achieving a high device implant success rate of 96%.

At a median follow-up of 173 days, 79% of patients showed significant improvement in their symptoms, with mild or no residual mitral regurgitation confirmed by echocardiography, indicating the procedure's efficacy in enhancing patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Experience With New Transcatheter Mitral Valve Replacement. Bapat, V., Rajagopal, V., Meduri, C., et al.[2022]

Mitral regurgitation (MR) is the most common type of heart valve disease, and while surgery is the standard treatment, many patients are at high risk for surgery.

Transcatheter mitral valve replacement (TMVR) is being explored as a safe and effective alternative for these high-risk patients, with early studies showing promising results in terms of feasibility and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest Advances in Transcatheter Mitral Valve Replacement. Hinohara, TT., Reardon, MJ., Goel, SS.[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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05688514?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Edwards%20Lifesciences%22)&viewType=Table&rank=9

TVMR With the Innovalve System Trial - First In Human Israel Clinically significant, symptomatic mitral regurgitation · High risk for open-heart surgery · Meets anatomical criteria.

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015298

TMVR for the Treatment of Mitral Regurgitation: A State-of- ... The 30-day and 1-year all-cause mortality rates were low (0% and 6.7%, respectively), whereas 22.3% of patients were hospitalized for ...

3. withpower.com withpower.com/trial/phase-1-mitral-valve-insufficiency-8-2021-e2833

Innovalve Artificial Mitral Valve for Mitral Valve Regurgitation The Mi-thos TMVR system was successfully implanted in all 10 high-risk patients with severe mitral regurgitation, demonstrating a 100% intraoperative success ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05682066

NCT05682066 | TVMR With the Innovalve System Trial Study to evaluate the safety and performance of the Innovalve mitral valve replacement system ... Mitral Valve Regurgitation (Degenerative or Functional). Mitral ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666496823000195

Innovalve transcatheter mitral valve replacement system The Innovalve bioprosthesis was successfully implanted in all of the animals with accurate positioning, anchoring and good paravalvular sealing.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10198241/

Transcatheter Mitral Valve Replacement with Dedicated ... Thirty-five patients with severe MR and high surgical risk underwent TMVR using the Sapient M3 system, with successful implant seen in 89% (31/ ...