958 Participants Needed

Tendyne Transcatheter Mitral Valve System for Mitral Regurgitation

(SUMMIT Trial)

Recruiting at 69 trial locations
KD
LO
Overseen ByLeslie Ornelas
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abbott Medical Devices
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device.The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort.Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

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.

Is the Tendyne Transcatheter Mitral Valve System generally safe for humans?

The Tendyne Transcatheter Mitral Valve System has been studied for its safety in humans, with early results showing it may be a safe and less invasive option for treating mitral valve disease. Studies have shown promising outcomes for patients, and the device is repositionable and retrievable, which adds to its safety profile.12345

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 fully repositionable and retrievable transcatheter mitral valve replacement, offering a less invasive option for patients who are not suitable for conventional surgery. It provides an alternative to transcatheter edge-to-edge repair, especially for high-risk patients with severe mitral valve disease.34567

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

The Tendyne Transcatheter Mitral Valve System has shown promising results in early studies, suggesting it may be a safe and effective treatment for patients with severe mitral valve disease who cannot undergo traditional surgery. Short-term follow-up indicates it could be a good alternative for high-risk patients.34567

Who Is on the Research Team?

Gorav Ailawadi, M.B.A., M.D. - BME

Gorav Ailawadi

Principal Investigator

University of Michigan

JR

Jason Rogers

Principal Investigator

University of California, Davis

RP

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
See 1 more

Exclusion Criteria

Your heart's pumping function is very low, less than 25%.
Your heart's left ventricle is larger than 7.0 cm when it is full of blood.
I have had surgery or a procedure on my mitral valve that involved putting in artificial material.
See 7 more

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?
5Treatment groups
Experimental Treatment
Active Control
Group I: Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) CohortExperimental Treatment1 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) CohortExperimental Treatment1 Intervention
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System
Group III: Randomized Cohort - Treatment GroupExperimental Treatment1 Intervention
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Group IV: Non-repairable CohortExperimental Treatment1 Intervention
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Group V: Randomized Cohort - Control GroupActive Control1 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

Find a Clinic Near You

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 profile image

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford profile image

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

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

Citations

Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. [2023]
Early clinical results with the Tendyne transcatheter mitral valve replacement system. [2020]
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]
Transcatheter mitral valve implantation with Tendyne System Ten Years since the First In-Human Implant A systematic review. [2023]
Transcatheter Mitral Valve Replacement with Tendyne. [2020]
Transapical Transcatheter Mitral Valve Implantation with the Tendyne Valve: The Swiss Experience. [2023]
Current Devices in TMVI and Their Limitations: Focus on Tendyne. [2021]
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