Tendyne Mitral Valve System for Mitral Regurgitation

Recruiting at 35 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must not be taking: Anticoagulants, Antibiotics

Disqualifiers: Severe mitral stenosis, Thrombus, Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate (procedure-based)

191 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be on guideline-directed medical therapy, which suggests you may need to continue certain treatments.

What data supports the effectiveness of the Tendyne Mitral Valve System treatment for mitral regurgitation?

The Tendyne Mitral Valve System has shown promising results in early studies, suggesting it may be a safe and effective treatment for mitral regurgitation, especially for patients who are not suitable for traditional surgery. Short-term follow-up indicates it could be a good alternative for high-risk patients with severe mitral valve disease. ^{1 2 3 4 5}

Is the Tendyne Mitral Valve System safe for humans?

The Tendyne Mitral Valve System has been studied for over ten years, with early feasibility studies showing promising safety results. It is a repositionable and retrievable device, and long-term outcomes from initial human trials are encouraging, suggesting it may be a safe option for treating mitral valve disease. ^{1 2 3 6 7}

How is the Tendyne Mitral Valve System treatment different from other treatments for mitral regurgitation?

The Tendyne Mitral Valve System is unique because it is a transcatheter mitral valve replacement (TMVR) that is fully repositionable and retrievable, offering a less invasive option for patients who are not suitable for traditional surgery or other repair methods. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with severe mitral valve regurgitation who are at least NYHA Class II and not suitable for traditional surgery. Candidates should not have conditions like severe heart calcification, recent heart attacks, or life expectancy less than a year due to other diseases.

Inclusion Criteria

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

A team of heart specialists has decided I can't have standard heart surgery.

My heart condition affects my daily life even with treatment.

Exclusion Criteria

I have a blood clot in my heart's left side.

Pregnant, lactating, or planning pregnancy within next 12 months

Participating or planning participation in an investigational drug or another device study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients will undergo transcatheter mitral valve replacement using the Tendyne Mitral Valve System

Immediate (procedure-based)

1 visit (in-person for procedure)

Initial Follow-up

Participants are monitored for safety and performance of the device, including assessment of mitral regurgitation grade and adverse events

30 days

1 visit (in-person)

Long-term Follow-up

Follow-up evaluations will be conducted to assess the long-term safety and performance of the Tendyne Mitral Valve System

5 years

Treatment Details

Interventions

• Tendyne Mitral Valve System

Trial Overview The Tendyne Mitral Valve System is being tested to see if it's safe and works well in treating severe mitral regurgitation in patients who can't undergo standard surgical treatments. Participants will be monitored for five years after the device implantation.

Participant Groups

Group I: Tendyne Mitral Valve System Experimental Treatment 1 Intervention

Patients will undergo transcatheter mitral valve replacement

Tendyne Mitral Valve System is already approved in European Union for the following indications:

Approved in European Union as Tendyne Transcatheter Mitral Valve System for:

• Symptomatic, moderate-to-severe or severe mitral regurgitation
• Severe mitral annular calcification

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

Transcatheter mitral valve replacement, particularly the Tendyne system, is a promising new technology for treating mitral valve regurgitation, showing encouraging results in early feasibility studies in the U.S.

The Tendyne system is designed to be fully repositionable and retrievable, suggesting it may offer a safer and less invasive treatment option for patients with mitral valve disease, with a pivotal randomized trial currently underway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early clinical results with the Tendyne transcatheter mitral valve replacement system. Beller, JP., Rogers, JH., Thourani, VH., 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]

The Tendyne™ valve system for transcatheter mitral valve replacement (TMVR) has shown a high technical success rate of 96.9% across 319 patients, indicating its effectiveness as a treatment option for mitral valve disease.

Postoperative outcomes demonstrated significant improvements in mitral regurgitation (MR) severity, with most patients experiencing lower MR grades after the procedure, suggesting that TMVR with the Tendyne valve is a promising minimally invasive approach for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve implantation with Tendyne System Ten Years since the First In-Human Implant A systematic review. Ahmed, A., Aziz, TAA., AlAsaad, MMR., et al.[2023]

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 of 63 patients eligible for the Tendyne system, those who underwent transcatheter mitral valve replacement (TMVR) experienced a significant reduction in mitral regurgitation severity, with 94.1% achieving less than 1+ MR at discharge, and greater left ventricular reverse remodeling at 30 days compared to those treated with transcatheter edge-to-edge repair (TEER).

However, TMVR with the Tendyne system was associated with a higher 30-day mortality rate compared to TEER, although mortality rates between 30 days and one year were similar for both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. Wilde, N., Tanaka, T., Vij, V., et al.[2023]

In a study of 24 patients undergoing transcatheter mitral valve implantation with the Tendyne system, the technical success rate was high at 96%, indicating that the procedure is effective for treating complex mitral valve disease.

The perioperative risks were manageable, with no deaths within 30 days, although there were some complications such as one stroke and three major bleeding events, suggesting that while the procedure is generally safe, careful monitoring is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transapical Transcatheter Mitral Valve Implantation with the Tendyne Valve: The Swiss Experience. Nucera, M., Miazza, J., Praz, F., et al.[2023]

The Tendyne™ valve is the only CE-approved transcatheter mitral valve implant, designed to be repositionable and retrievable, which addresses challenges in treating mitral valve regurgitation (MR).

In an early feasibility study involving 100 patients, the Tendyne™ valve showed promising results for treating MR and also demonstrated potential for use in patients with mitral annular calcification over a 1 to 2 year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Devices in TMVI and Their Limitations: Focus on Tendyne. Dahle, G.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

Early clinical results with the Tendyne transcatheter mitral valve replacement system. [2020]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve implantation with Tendyne System Ten Years since the First In-Human Implant A systematic review. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement with Tendyne. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Transapical Transcatheter Mitral Valve Implantation with the Tendyne Valve: The Swiss Experience. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Current Devices in TMVI and Their Limitations: Focus on Tendyne. [2021]