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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 30-day
Awards & highlights
Summary
This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy
Eligible Conditions
- Heart Failure
- Cardiomyopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety outcome: 30-day major adverse events (MAEs)
Secondary study objectives
Clinical outcome: Freedom from re-hospitalizations or re-interventions for the underlying condition
Clinical outcome: Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL)
Clinical outcome: Improvement in NYHA functional class
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Who is running the clinical trial?
Ancora Heart, Inc.Lead Sponsor
8 Previous Clinical Trials
488 Total Patients Enrolled
6 Trials studying Heart Failure
464 Patients Enrolled for Heart Failure
Michael Zapien, MS, CCRAStudy DirectorAncora Heart, Inc.
3 Previous Clinical Trials
62 Total Patients Enrolled
3 Trials studying Heart Failure
62 Patients Enrolled for Heart Failure
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