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Device
Cardioband System for Mitral Regurgitation (ACTIVE Trial)
N/A
Waitlist Available
Led By Brian Whisenant, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
ACTIVE Trial Summary
This trial will test the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation.
Eligible Conditions
- Mitral Regurgitation
- Mitral Valve Regurgitation
ACTIVE 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
Number of Participants With Major Adverse Events (MAE) [Device Group Only]
Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].
Secondary outcome measures
Clinical Success
Device Success
Procedural Success
+2 moreACTIVE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Roll-In - Edwards Cardioband SystemExperimental Treatment2 Interventions
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Group II: Randomized - Edwards Cardioband SystemExperimental Treatment2 Interventions
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Group III: Randomized - ControlActive Control1 Intervention
Guideline directed medical therapy (GDMT)
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,562 Total Patients Enrolled
Mark Reisman, MDStudy ChairUniversity of Washington
3 Previous Clinical Trials
1,910 Total Patients Enrolled
Brian Whisenant, MDPrincipal InvestigatorIntermountain Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: Mainly degenerative mitral regurgitationYou have a condition called mitral annular calcification that would make it difficult to put in the device.You have serious problems with your heart valves that need treatment.You have a mitral valve anatomy that may make it difficult to place the Edwards Cardioband correctly.You have a serious problem with how your mitral valve works.You have heart failure symptoms.You have been hospitalized for heart failure or have high levels of BNP in the last 12 months.You are expected to live for less than one year.You have other medical, social, or psychological conditions that make it difficult for you to understand and follow the study requirements.You are older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized - Edwards Cardioband System
- Group 2: Randomized - Control
- Group 3: Roll-In - Edwards Cardioband System
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.
Are people with the necessary qualifications still able to join this trial?
"According to the listing on clinicaltrials.gov, this study has stopped recruiting patients. The clinical trial was first posted on 6/1/2017 and was edited on 6/9/2020. Although this study is not enrolling patients, there are other trials that are still looking for participants."
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