Tendyne Mitral Valve System for Mitral Regurgitation

No longer recruiting at 42 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and performance of the Tendyne Mitral Valve System, a transcatheter mitral valve replacement, for individuals with severe mitral regurgitation. This condition causes the heart's mitral valve to leak, leading to backward blood flow. The trial targets patients who struggle with daily activities due to their condition and cannot undergo traditional surgery. Suitable participants should have severe mitral valve leakage and experience limitations in daily activities despite treatment. As an unphased trial, it offers patients the chance to contribute to medical advancements and potentially enhance their quality of life.

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 prior data suggests that the Tendyne Mitral Valve System is safe for treating mitral regurgitation?

Research has shown that the Tendyne Mitral Valve System is generally well-tolerated by patients with severe mitral regurgitation. This condition occurs when the heart's mitral valve doesn't close properly, causing blood to flow backward in the heart. One study found that the procedure was performed correctly in 95% of cases and successfully stopped the backward blood flow in all patients studied.

However, 39% of patients died from any cause within two years. While this number might seem high, it is considered acceptable because the patients were older and had other health issues. In simpler terms, some patients did not survive long-term, but this was expected due to their overall health.

Overall, the Tendyne Mitral Valve System has demonstrated positive results for immediate safety and effectiveness. However, like any medical procedure, there are risks, especially for patients who are already very sick. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Tendyne Mitral Valve System is unique because it offers a transcatheter approach to mitral valve replacement, which is less invasive than traditional open-heart surgery. Unlike conventional surgical valve repair or replacement, this system allows doctors to replace the mitral valve without opening the chest, potentially reducing recovery time and risks associated with surgery. Researchers are excited about this treatment because it could provide a safer and more accessible option for patients who are too high-risk for standard surgical procedures.

What evidence suggests that the Tendyne Mitral Valve System is effective for severe mitral regurgitation?

Research has shown that the Tendyne Mitral Valve System, which participants in this trial will receive, can effectively treat severe mitral regurgitation, a condition where the heart's mitral valve doesn't close properly. In earlier studies, the valve replacement succeeded in over 94% of patients, with a low 30-day death rate of about 7%. Another study found a high success rate of 98% for the procedure, with few remaining issues with the heart valve. After six months, 60% of patients met the main goal of the study, surpassing the expected rate of 43%. Many patients also reported a significant improvement in their quality of life. Overall, the Tendyne Mitral Valve System has shown promising results as a less invasive treatment option. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.10.025

Transcatheter Mitral Valve Replacement for Severe ... Technical success was achieved in 94.2%, with a 30-day mortality of 6.8%. The primary endpoint was met − freedom from all-cause mortality and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6288215/

Early clinical results with the Tendyne transcatheter mitral ... The Tendyne transcatheter mitral valve replacement valve may prove to be a safe, less invasive approach to treatment of mitral valve disease.

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

TMVR for the Treatment of Mitral Regurgitation: A State-of- ... In the first pilot trial (50 patients), the 30-day mortality rate was 14%, with a procedural success rate of 98% and mild or no residual MR ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03433274

NCT03433274 | Clinical Trial to Evaluate the Safety and ... This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System

5. acc.org acc.org/Latest-in-Cardiology/Articles/2025/10/24/16/56/mon-244pm-summit-tct-2025

SUMMIT-MAC: Is TMVR With Tendyne Successful in ... Of note, the primary endpoint was met: 60% at six months, beating the performance goal of 43%. Moreover, QOL improved significantly (18±24 ...

6. jacc.org jacc.org/doi/10.1016/j.jcin.2024.05.020

3-Year Outcome of Tendyne Transcatheter Mitral Valve ... 3-year outcome of Tendyne transcatheter mitral valve replacement to treat severe symptomatic mitral valve regurgitation.

7. structuralheart.abbott structuralheart.abbott/int/products/transcatheter-mitral-valve-repair/tendyne-tmvr-clinical-data

Tendyne TMVR Clinical Data The 2-year all-cause mortality rate of 39% is an acceptable mid-term safety profile considering the advanced age and underlying comorbities in this population.1 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9896404/

Early outcomes of transcatheter mitral valve replacement with ... In this study of Tendyne TMVR in severe MAC, there were high rates of technical success (95%), elimination of MR (100%), and safety (i.e., no procedural ...