The Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms is a prospective, multicenter, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio.
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 treat 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).
CRITERIA LIST/ QUALIFICATIONS:
- Age 18-80
- LV Aneurysm/Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar
- LV Aneurysm/Scar Location: Defined as a scar involving septum and anterior, apical or anterolateral regions of the lef ventricle as evidenced by cvardiac imaging and referred for surgical management
- Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging
- Left Ventricular Ejection Fraction <45%
- Left ventricular end-systolic volume index .50 mL/m2
- Suffering from heart failure symptoms as defined by NYHA Classification >2 not responsive to medical therapy
- Patient completed 6 Minute Walk Test and MLHF Quality of Life Questionnaire
- Patient is on adequate GDMT
- Subject must provide written informed consent
- Agree to required follow-up visits
Peter Eckman, MD