Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment with the Revivent TC System |
|
| Control Pool | No Intervention | Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revivent TC | Device | Treatment of LV scar |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Candidates allocated to active concurrent control pool of patients must meet all inclusion criteria (including LV Aneurysm/Scar Presence), WITH THE EXCEPTION OF ONE OF THE FOLLOWING:
Exclusion Criteria:
Candidates will be excluded from the study and active concurrent control group if ANY of the following conditions are present:
The following exclusion criteria apply only to the treatment group and do not apply to the concurrent control cohort:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew S Wechsler, MD | Drexel University College of Medicine | Principal Investigator |
| Gregg W Stone, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Jerry D Estep, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute | Phoenix | Arizona | 85004 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39797846 | Derived | 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. |
| Label | URL |
|---|---|
| Sponsor Web Site | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Ronald Regan UCLA Medical Center |
| Los Angeles |
| California |
| 90024 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | United States |
| Baptist Hospital of Maimi | Miami | Florida | 33176 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| WellStar Health System | Marietta | Georgia | 30060 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Terrebonne General Medical Center | Houma | Louisiana | 70360 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5856 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Wake Forest Baptist Hospital | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| UPMC Pinnacle | Harrisburg | Pennsylvania | 17101 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| CHI St. Luke's Health-Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| Nemocnice Na Homolce | Prague | 150 30 | Czechia |
| Hygeia Hospital | Athens | 151 23 | Greece |
| Interbalkan Medical Center | Thessaloniki | Greece |
| Papworth Hospital NHS Foundation Trust | Cambridge | CB23 3RE | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided