Innovalve Artificial Mitral Valve for Mitral Valve Regurgitation

(TWIST-EFS Trial)

Recruiting at 12 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

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Innovalve mitral valve replacement system. It is designed for patients who need their mitral valve replaced due to severe damage. The device works by taking over the function of the damaged valve to ensure proper blood flow in the heart.

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 data supports the effectiveness of the Innovalve MR system, Innostay TMVR System, and Innovalve TMVR System treatment for mitral valve regurgitation?

Transcatheter mitral valve replacement (TMVR) has shown promise as a treatment for severe mitral regurgitation, especially in patients who are not suitable for traditional surgery. Early clinical experiences with TMVR, including the use of devices like the Tendyne prosthesis, suggest it can be a safe and effective alternative for high-risk patients. ^{1 2 3 4 5}

Is the Innovalve Artificial Mitral Valve safe for humans?

There is no specific safety data available for the Innovalve Artificial Mitral Valve or its other names. However, early experiences with similar transcatheter mitral valve replacement (TMVR) systems have shown feasibility in high-risk patients, but more studies are needed to confirm safety. ^{2 4 6 7 8}

How is the Innovalve MR system treatment different from other treatments for mitral valve regurgitation?

The Innovalve MR system is a type of transcatheter mitral valve replacement (TMVR), which is a newer treatment option for patients with severe mitral valve regurgitation who are at high risk for traditional surgery. Unlike conventional surgery, TMVR is less invasive and can be performed through a catheter, making it suitable for patients who cannot undergo open-heart surgery. ^{3 4 5 9 10}

Research Team

Chet Rihal

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

MV replacement with Innovalve MR 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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2019]

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

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

3. France pubmed.ncbi.nlm.nih.gov

Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. [2023]

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

Early Experience With New Transcatheter Mitral Valve Replacement. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement with Tendyne. [2020]

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

Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. [2023]

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

Transcatheter Mitral Valve Replacement in Patients With Previous Aortic Valve Replacement. [2019]

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

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System. [2021]

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

Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Latest Advances in Transcatheter Mitral Valve Replacement. [2022]