Initiation and Titration of Guideline Directed Medical Therapy in Heart Failure Cardiogenic Shock With Impella 5.5 for Cardiac Recovery: INTeGRATE
Abiomed Inc.
Summary
The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.
Description
This is a prospective, single arm, multi-center, post-market, on-label study. Patients presenting with heart failure cardiogenic shock (HF-CS), an intentional device-supported strategy with Impella 5.5 for optimization of guideline-directed medical therapy (GDMT) combined with best practices improves outcomes over standard of care. The study objectives are to evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 and \< 80 years 2. Subject has signed the Informed Consent Form. If the subject has been enrolled via an LAR, the subject must provide assent, the assent will be documented. 3. LVEF ≤ 40% 4. Subject is presenting with decompensated heart failure and meets at least one (1) of the following cardiogenic shock criteria: 1. Sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure. 2. Cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the a…
Interventions
- DeviceImpella 5.5 SmartAssist
The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.
Locations (7)
- Tampa General HospitalTampa, Florida
- Abbott NorthwesternMinneapolis, Minnesota
- Rutgers-Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey
- Atrium HealthCharlotte, North Carolina
- Duke UniversityDurham, North Carolina
- University of Pennsylvania Health SystemPhiladelphia, Pennsylvania