BioVentrix Revivent TC™ System Clinical Study
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|ClinicalTrials.gov Identifier: NCT02931240|
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Dysfunction, Left||Device: Revivent TC||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)|
|Actual Study Start Date :||August 29, 2017|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||December 31, 2025|
Treatment with the Revivent TC System
Device: Revivent TC
Treatment of LV scar
No Intervention: Control Pool
Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only
- 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. [ Time Frame: 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). [ Time Frame: 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.
- 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. [ Time Frame: 1 year ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931240
|Contact: Noel Messenger, MBA||(925)830-1000 ext firstname.lastname@example.org|
|Principal Investigator:||Andrew S Wechsler, MD||Drexel University College of Medicine|