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Transcatheter Mitral Valve System
Tendyne Transcatheter Mitral Valve System for Mitral Regurgitation (SUMMIT Trial)
N/A
Recruiting
Led By Jason Rogers, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
SUMMIT Trial Summary
This trial will investigate the safety and effectiveness of a new device to treat mitral valve disease, compared to the current standard of care device. The trial will enroll patients who are not suitable for surgery, as well as those with severe mitral annular calcification.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include complications related to heart procedures like bleeding, infection risk at the catheter insertion site, irregular heartbeats, stroke risks or damage to surrounding structures such as blood vessels or other valves.
SUMMIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition limits my physical activity but I can still walk.
Select...
I have severe heart valve leakage or severe valve calcification.
SUMMIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-repairable Cohort
Randomized Cohort
Severe MAC Continued Access Protocol (MAC CAP) Cohort
+1 moreSecondary outcome measures
Change from baseline in New York Heart Association Classification
Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT)
Change from baseline in health outcomes, as measured by the EQ-5D
+2 moreSUMMIT Trial Design
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
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
403,538 Total Patients Enrolled
Kartik Sundareswaran, PhDStudy DirectorAbbott Structural Heart
5 Previous Clinical Trials
2,447 Total Patients Enrolled
Jason Rogers, MDPrincipal InvestigatorUniversity of California, Davis
4 Previous Clinical Trials
833 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart condition limits my physical activity but I can still walk.I have severe heart valve leakage or severe valve calcification.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.I have a serious heart valve issue needing surgery.Your heart and blood vessel anatomy is not suitable for the device to be implanted.I need surgery or a catheter-based procedure for my aortic valve condition.I have no surgeries planned 60 days before or after joining the study.My non-heart related health issues are not expected to limit my life to under a year.I have a growth on my mitral heart valve.I am on hemodialysis for chronic kidney failure.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized Cohort - Control Group
- Group 2: Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort
- Group 3: Non-repairable Cohort
- Group 4: Randomized Cohort - Treatment Group
- Group 5: Severe Mitral Annular Calcification (MAC) Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current breadth of hospitals conducting this trial?
"As of now, 77 sites are accepting patients for this trial. These locations span from Memphis to Oak Lawn and Kansas City, in addition to other centres. To reduce travel requirements it is best to pick the location most proximate to you when registering."
Answered by AI
Is this research endeavor accepting participants at this time?
"Affirmative. The clinical trial has been published on the website of clinicaltrials.gov, revealing that it is actively recruiting patients from 77 sites across the world. This project was first posted in June 2018 and its information was most recently updated 13th June 2022 with a goal to enlist 958 participants for this research endeavour."
Answered by AI
How many participants are taking part in this research endeavor?
"The sponsor, Abbott Medical Devices, necessitates the recruitment of 958 suitable participants for this trial. The study will be conducted from multiple locations including Baptist Memorial Hospital in Memphis and Advocate Christ Medical Center located Oak Lawn."
Answered by AI
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