Phase
Condition
N/ATreatment
Revivent System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years old or older
LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar
LV Aneurysm/Scar Location: Defined as a scar involving anterior, apical oranterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion asevidenced by cardiac imaging)
Left Ventricular Ejection Fraction < 40%
Left ventricular end-systolic volume index ≥60 mL/m2
Suffering from heart failure symptoms as defined by NYHA Classification > 2 notresponsive to medical therapy
Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can beperformed at baseline visit)
Patient is on adequate Guideline Directed Medical Therapy (GDMT)
Subject or a legally authorized representative must provide written informed consent
Agree to required follow-up visits
Female subject of childbearing potential does not plan pregnancy for at least oneyear following the index procedure. For a female of childbearing potential, apregnancy test must be performed with negative results known within seven days priorto index procedure
Exclusion
Exclusion Criteria:
Candidates will be excluded from the study if ANY of the following conditions is present:
Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days priorto enrollment
Valvular heart disease, which in the opinion of the investigator, will requireintervention (transcatheter or surgical)
Mitral Regurgitation greater than moderate (>2+)
Need for coronary revascularization, in the opinion of the investigator
Peak Systolic Pulmonary Arterial Pressure > 70 mm Hg via echo or right heartcatheterization
Myocardial Infarction within 90 days prior to enrollment
Within the last six months, a prior CVA or TIA, or intracranial hemorrhage
Co-morbid disease process with life expectancy of less than one year or activemalignancy not in remission
Severe pulmonary disease that would preclude general anesthesia
Any solid organ transplant or is on waiting list for any solid organ transplantother than cardiac
Chronic renal failure with a GFR<30ml/min
Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint
Study Design
Study Description
Connect with a study center
Banner University Medical Center
Phoenix 5308655, Arizona 5551752 85012
United StatesActive - Recruiting
Baptist Health South Florida
Miami 4164138, Florida 4155751 33143
United StatesActive - Recruiting
University of Chicago
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
Saint Luke's Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64131
United StatesActive - Recruiting
Oklahoma Heart Hospital
Oklahoma City 4544349, Oklahoma 4544379 73120
United StatesActive - Recruiting
Penn State Health
Hershey 5193342, Pennsylvania 6254927 717033
United StatesActive - Recruiting

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