Tendyne Transcatheter Mitral Valve System for Mitral Regurgitation
(SUMMIT Trial)
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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-procedure
Participants undergo pre-procedure assessments and preparation
Procedure
Participants receive the Tendyne Transcatheter Mitral Valve System or MitraClip system
Post-procedure
Participants are monitored immediately after the procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MitraClip System
- Tendyne Mitral Valve System
Tendyne Mitral Valve System is already approved in European Union for the following indications:
- 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
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