The INNOVATE Trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study comparing the BrioVAD System to the HM3 LVAS. The primary objective is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.
INNOVATE
Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)
Advanced heart failure, Cardiovascular diseases, Heart disease
All genders
18+
Recruiting now
Overview
Principal Investigator: Gaurav Gulati, MD
Contact Us
Gaurav Das/Abena Adwetewa-Badu (Abena.Adwetewa-Badu@tuftsmedicine.org)
Study details
Inclusion Criteria
- Patient is classified as NYHA Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.
- Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or < 30% on inotropes or temporary MCS.
- Patient is inotrope dependent, or has a cardiac index (CI) ≤ 2.2 liters/min/m2, while not on inotropes, and also meets one of the following criteria:
- Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 of the 60 days and is failing to respond or is not able to tolerate OMM; or
-Has advanced heart failure for at least 14 days and is dependent on an IABP or similar temporary MCS device (MCSD) for at least seven days.
Exclusion Criteria
- Patient’s heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative disease), complex congenital heart disease (e.g., transposition of the great vessels), uncorrected thyroid disease, and/or pericardial disease.
- Patient had a myocardial infarction within seven days of study enrollment.
- Patient had cardiothoracic surgery within 30 days of implant with the exception of a procedure to implant temporary MCS: Impella 5.5, Impella CP or TandemHeart.
Study Requirements
We expect that you will be in this research study for up to 24 months, after the study device is implanted, and you will be asked to come to the study center at 1, 3, 6, 12, 18, and 24 months post-implant during which we will complete blood tests, neurological tests, quality of life assessments, and echocardiograms.
Two to three teaspoons of blood will be taken at each visit.