BioVentrix Revivent TC™ System Clinical Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Revivent TC: Treatment of LV scar
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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. — 1 Month
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. - 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). — 1 Year
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.
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute | Phoenix | Arizona | |
| Ronald Regan UCLA Medical Center | Los Angeles | California | |
| University of California, San Francisco | San Francisco | California | |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | |
| Baptist Hospital of Maimi | Miami | Florida | |
| Emory University Hospital Midtown | Atlanta | Georgia | |
| WellStar Health System | Marietta | Georgia | |
| Memorial Medical Center | Springfield | Illinois | |
| Terrebonne General Medical Center | Houma | Louisiana | |
| University of Michigan | Ann Arbor | Michigan | |
| University of Minnesota Medical Center | Minneapolis | Minnesota | |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | |
| Hackensack University Medical Center | Hackensack | New Jersey | |
| Mount Sinai Hospital | New York | New York | |
| New York Presbyterian Hospital | New York | New York | |
| Wake Forest Baptist Hospital | Winston-Salem | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | |
| UPMC Pinnacle | Harrisburg | Pennsylvania | |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| CHI St. Luke's Health-Baylor St. Luke's Medical Center | Houston | Texas | |
| Houston Methodist Hospital | Houston | Texas | |
| Winchester Medical Center | Winchester | Virginia | |
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02931240 on ClinicalTrials.gov ↗ ← All trials in the UK