Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
126 participants
INTERVENTIONAL
2017-08-29
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Treatment with the Revivent TC System
Revivent TC
Treatment of LV scar
Control Pool
Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only
No interventions assigned to this group
Interventions
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Revivent TC
Treatment of LV scar
Eligibility Criteria
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Inclusion Criteria
* LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar;
* LV Aneurysm/Scar Location: Defined as a scar involving septum and/or anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management;
* Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging;
* Left Ventricular Ejection Fraction \< 45%;
* Left ventricular end-systolic volume index ≥50 mL/m2;
* Suffering from heart failure symptoms as defined by NYHA Classification \> 2 not responsive to medical therapy;
* Patient completed 6 Minute Walk Test and MLHF Quality of Life Questionnaire (can be performed 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; and
* They have undergone previous pericardiotomy, left thoracotomy, or open heart surgery, or
* The LV Aneurysm/Scar location does not permit treatment with the study device, or
* The patient elects to be enrolled in the control group
Exclusion Criteria
* Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 60 days prior to enrollment;
* Valvular heart disease, which in the opinion of the investigator, will require surgery;
* Functional Mitral Regurgitation greater than moderate (i.e. EROA\>20mm sq.) and degenerative MR (including MR due to papillary muscle rupture);
* Need for coronary revascularization, in the opinion of the site investigator;
* Peak Systolic Pulmonary Arterial Pressure \> 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale;
* Myocardial Infarction within 90 days prior to enrollment;
* Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology;
* Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission;
* Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac;
* Chronic renal failure with a serum creatinine \>2.5 mg/dL and/or GFR\<30ml/min;
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
* Presence of significant ventricular arrhythmias
* Contraindication or inability to adhere to systemic anticoagulation;
* Known hypersensitivity or contraindication to device materials;
* Previous pericardiotomy or left thoracotomy;
* Pathology/previous surgery/radiation therapy of the right neck that would interfere with placement of a 14F delivery catheter;
* Prior open heart surgery or significant pericarditis;
* Calcified ventricular wall in the area of intended anchor implants as verified by cardiac imaging;
* Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by cardiac imaging that has not been adequately treated with anticoagulant.
* Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;
18 Years
100 Years
ALL
No
Sponsors
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BioVentrix
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew S Wechsler, MD
Role: PRINCIPAL_INVESTIGATOR
Drexel University College of Medicine
Gregg W Stone, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Jerry D Estep, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute
Phoenix, Arizona, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
Baptist Hospital of Maimi
Miami, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
WellStar Health System
Marietta, Georgia, United States
Memorial Medical Center
Springfield, Illinois, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
UPMC Pinnacle
Harrisburg, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CHI St. Luke's Health-Baylor St. Luke's Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Winchester Medical Center
Winchester, Virginia, United States
Nemocnice Na Homolce
Prague, , Czechia
Hygeia Hospital
Athens, , Greece
Interbalkan Medical Center
Thessaloniki, , Greece
Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Estep JD, Ben-Yehuda O, Wechsler AS, Puri R, Kao AC, Heimes JK, Pfeiffer MP, Boehmer JP, Ninios V, Zaman A, Stone GW. Transcatheter Left Ventricular Reconstruction in Heart Failure Patients With Prior Anterior Myocardial Infarction: The Prospective ALIVE Trial. JACC Heart Fail. 2025 Feb;13(2):296-308. doi: 10.1016/j.jchf.2024.09.023. Epub 2025 Jan 8.
Related Links
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Sponsor Web Site
Other Identifiers
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CIP-0066
Identifier Type: -
Identifier Source: org_study_id
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