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A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.
The purpose of the study is to assess the safety and effectiveness of the BioVentrix Revivent System plus GDMT compared to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure.
Safety will be assessed compared with a Performance Goal based on surgical ventriculoplasty outcomes (MAE's at 30 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT) | Experimental | Medical Intervention through a mini thoracotomy, placement of anchors to plicate the scarred areas of the heart thereby reducing the left ventricle size and improving left ventricle mechanics. Subjects would continue on Guideline Directed Medical Therapy (GDMT) |
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| Guideline Directed Medical Therapy (GDMT) only | No Intervention | Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revivent System | Device | BioVentrix has developed the Revivent System to mirror Surgical Ventricular Restoration (SVR). The Revivent System is used to place permanent cardiac implants to the epicardial surface for the purpose of reconfiguring abnormal cardiac geometry that is contributing to the dysfunction. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events Composite Performance Goal | Composite of Major Adverse Events at 30 days comprised of Clinical Events Committee (CEC) Adjudication of Mortality, Myocardial Infarction (MI), Major Stroke, Prolonged Intubation >48hrs, Need for Inotropic support >24hrs, Mech circulatory support intra or post op, BARC 4 or 5 bleeding, reoperation, serious infection related to device or procedure, Cardiac tamponade, or Initiation of renal replacement therapy, with a Performance Goal (PG) of 70% (upper bound of the 97.5% one sided CI) | 30 days |
| Composite Effectiveness Endpoint | Using Finkelstein Schoenfeld (FS) hierarchical approach. This approach compares each treatment subject versus each control subject in a hierarchal fashion beginning with Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio. | 6 Months |
| Composite Effectiveness Endpoint | Using Finkelstein Schoenfeld (FS) hierarchical approach - Cardiovascular Mortality, Heart Transplant, Left Ventricular Assist Device (LVAD) Implantation, Hospital Readmission, Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
Candidates will be excluded from the study if ANY of the following conditions is present:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Chartier | Contact | (925) 830-1000 | 201 | schartier@bioventrix.com |
| Name | Affiliation | Role |
|---|---|---|
| Vinod THourani, MD | Piedmont Healthcare | Principal Investigator |
| Marat Fudim, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Recruiting | Phoenix | Arizona | 85012 | United States |
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| ID | Term |
|---|---|
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baptist Health South Florida | Recruiting | Miami | Florida | 33143 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| Saint Luke's Hospital of Kansas City | Recruiting | Kansas City | Missouri | 64131 | United States |
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| Oklahoma Heart Hospital | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
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| Penn State Health | Recruiting | Hershey | Pennsylvania | 717033 | United States |
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