A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.
The Revivent TC System is indicated for patients referred for surgical treatment of left ventricular scar that is contiguous, and includes both anterior and septal components. Primary and Secondary Effectiveness Endpoints will compare data from the patients treated with the Revivent TC System to a control pool of patients who comply with all aspects of the protocol except scar location and are not treated with the investigational devices but remain on Guideline Directed Medical Therapy (GDMT). The primary safety and effectiveness endpoints will be evaluated at 12 months post procedure. The study will be conducted at a maximum of 20 clinical centers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Treatment of LV scar
Incidence of all cause death, mechanical support, emergent cardiac surgery, prolonged mechanical ventilation, renal failure and clinically important stroke compared to data from the STS database for surgical LV aneurysm repair.
Composite primary safety endpoint of all cause death, placement of a mechanical support device intra or post-op (IABP, VAD, ECMO or catheter based), emergent cardiac surgery including reoperation for bleeding or tamponade, prolonged mechanical ventilation, renal failure and clinically important stroke (Rankin Score of 4 or higher) through 30-days post procedure. Data from the patients treated with the Revivent TC System will be compared to surgical outcomes data from the Society for Thoracic Surgery database for surgical LV aneurysm repair.
Time frame: 1 Month
The rate of all cause of death, mechanical support, and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months post procedure compared to untreated patients who remain on Guideline Directed Medical Therapy (GDMT).
A composite of all cause of death, placement of a mechanical support device and operation (or re-operation) for HF, bleeding or tamponade from 1 through 12 months (day 31 through 365) post procedure. Data from patients treated with the Revivent TC System will be compared to data from a control pool of patients who comply with all aspects of the protocol except scar (aneurysm) location and are not treated with the investigational devices remain on Guideline Directed Medical Therapy (GDMT). Patients in the GDMT group will be evaluated from day 31 through 365 after the date of enrollment into the study.
Time frame: 1 Year
The rate of re-hospitalization and improvement of HF Symptoms in patients treated with the test device compared to patients who are maintained on Guideline Directed Medical Therapy.
Composite primary effectiveness endpoint consisting of: * No hospital readmission for new or worsening heart failure, and * Improvement in MLHF Quality of Life score by \>10 points, and * Improvement in 6 Minute Walk Distance by \>25 meters, and * Improvement in NYHA Classification \> 1 grade.
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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
...and 20 more locations
Time frame: 1 year