Tendyne Transcatheter Mitral Valve System for Mitral Regurgitation

(SUMMIT Trial)

Recruiting at 71 trial locations

Overseen By Leslie Ornelas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Mitral vegetation, Ejection fraction < 25%, 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: 34

958 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Tendyne Transcatheter Mitral Valve System to determine its safety and effectiveness in treating mitral regurgitation, a heart valve issue where blood flows backward into the heart. The trial compares the Tendyne system with another treatment, the MitraClip, for certain participants, while others receive only the Tendyne system. It targets individuals with noticeable symptoms from moderate-to-severe mitral regurgitation or severe mitral annular calcification, a type of calcium build-up in the heart valve area. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance treatment options for heart valve conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that the Tendyne Transcatheter Mitral Valve System is generally well-tolerated. In earlier studies, the Tendyne system successfully placed the device 95% of the time and reduced mitral regurgitation (MR), effectively stopping the backward flow of blood through the heart's mitral valve. Importantly, no major safety concerns arose during the procedures, suggesting the device is safe for very sick patients with no other options.

Additionally, the FDA has approved the Tendyne system for use in certain patients, indicating it has met safety standards based on previous studies. This approval applies to patients whose mitral valves malfunction due to calcium buildup. This background information demonstrates that the Tendyne system has undergone safety testing in humans. However, always consider discussing personal risks with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Tendyne Transcatheter Mitral Valve System because it offers a new approach to treating mitral regurgitation, especially for patients with complex conditions like severe mitral annular calcification. Unlike traditional surgical options or the MitraClip system, the Tendyne system is delivered through a minimally invasive transcatheter method, which can be a game-changer for patients who are not candidates for open-heart surgery. Its unique design allows it to be customized to the patient's anatomy, potentially improving outcomes and reducing recovery times. This innovative approach could expand treatment possibilities and improve quality of life for patients who previously had limited options.

What evidence suggests that this trial's treatments could be effective for mitral regurgitation?

Research has shown that the Tendyne Transcatheter Mitral Valve System, which participants in this trial may receive, effectively treats mitral regurgitation, a condition where a heart valve leaks. Studies have found a high success rate of 94.2% for the procedure, with improvements in heart function and symptoms. For those with severe hardening of the valve area, the Tendyne system has produced positive results, such as fewer symptoms and an improved quality of life. Additionally, patients at high risk for traditional surgery have experienced shorter hospital stays and good survival rates with this treatment. Overall, the Tendyne system offers a promising alternative to more invasive heart surgeries. Meanwhile, the MitraClip System, used in the control group of this trial, serves as another treatment option for mitral regurgitation. ^{1 2 3 4 6}

Who Is on the Research Team?

Gorav Ailawadi

Principal Investigator

University of Michigan

Jason Rogers

Principal Investigator

University of California, Davis

Ryan Palmer, PhD

Principal Investigator

Abbott Structural Heart

Are You a Good Fit for This Trial?

This trial is for people with symptomatic mitral valve regurgitation or severe calcification who've been treated according to standards, are not in a vulnerable group, and have a life expectancy over 12 months. It's not for those with certain heart dimensions, previous mitral treatments, other severe valve diseases, or on hemodialysis.

Inclusion Criteria

My heart condition limits my physical activity but I can still walk.

I have severe heart valve leakage or severe valve calcification.

The local site heart team determines that the subject has been adequately treated per applicable standards

Exclusion Criteria

Your heart's pumping function is very low, less than 25%.

Your heart and blood vessel anatomy is not suitable for the device to be implanted.

Your heart's left ventricle is larger than 7.0 cm when it is full of blood.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-procedure

Participants undergo pre-procedure assessments and preparation

1 week

1 visit (in-person)

Procedure

Participants receive the Tendyne Transcatheter Mitral Valve System or MitraClip system

1 day

1 visit (in-person)

Post-procedure

Participants are monitored immediately after the procedure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at discharge, 30 days, 3 months, 6 months, and annually

What Are the Treatments Tested in This Trial?

Interventions

• MitraClip System
• Tendyne Mitral Valve System

Trial Overview The SUMMIT trial compares the Tendyne Transcatheter Mitral Valve System to the MitraClip system in patients with moderate-to-severe mitral regurgitation. Some groups will only receive the Tendyne device. The study aims to assess safety and effectiveness through regular follow-ups over five years.

How Is the Trial Designed?

Group I: Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort Experimental Treatment 1 Intervention

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort

Group II: Severe Mitral Annular Calcification (MAC) Cohort Experimental Treatment 1 Intervention

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System

Group III: Randomized Cohort - Treatment Group Experimental Treatment 1 Intervention

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Group IV: Non-repairable Cohort Experimental Treatment 1 Intervention

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Group V: Randomized Cohort - Control Group Active Control 1 Intervention

Treatment of mitral regurgitation within commercially approved MitraClip system indications

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

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]

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]

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]

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 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 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]

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]

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. tctmd.com tctmd.com/news/tendyne-safely-reduces-mr-patients-severe-calcification-summit-mac

Tendyne Safely Reduces MR in Patients With Severe ... SAN FRANCISCO, CA—Transcatheter mitral valve replacement (TMVR) with the Tendyne system (Abbott) successfully treats mitral regurgitation (MR) ...

3. 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

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

Early outcomes of transcatheter mitral valve replacement with ... In patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement.

5. sciencedirect.com sciencedirect.com/science/article/pii/S295060502500004X

Comparative midterm results of surgical mitral valve ... Compared with surgical MVR, TMVR demonstrated its effectiveness in high-risk patients, with shorter hospitalization time, acceptable survival, and improvement ...

6. abbott.mediaroom.com abbott.mediaroom.com/2025-05-27-Abbott-Receives-FDA-Approval-for-Tendyne-TM-,-First-of-Its-Kind-Device-to-Replace-the-Mitral-Valve-Without-Open-Heart-Surgery

Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind ... The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, ...