RECOVER IV Randomized Controlled Trial
RECOVER IV randomized controlled trial (RCT) is designed to provide the clinical evidence which, if positive, can lead to an upgrade of the European Class IIa guideline recommendation to a global Class I guideline recommendation for Impella® products and Impella best practices in treating AMI cardiogenic shock. The trial’s goal is to enroll 560 patients at up to 50 research sites in the U.S. and Europe.
RECOVER IV is an on-label, two-arm RCT:
In the Impella arm, patients will receive the portfolio of Impella products incorporating best practices validated over the last 10 years in more than 100,000 AMI cardiogenic shock patients. These protocols include early identification of shock, minimization of inotropes, Impella implantation before initiating PCI, identification of right heart failure and need for oxygenation. The goal for this therapy is higher survival rates with native heart recovery (recovery of ejection fraction), shorter length of hospital stay and avoidance of implantable left ventricular assist devices (LVADs) and heart transplant.
The control group will receive conventional treatments, including inotropes, vasopressors, IAB, ECMO and other forms of MCS. From a randomization perspective, ECMO provides another alternative to hemodynamic support beyond IAB. However, ECMO comes with complications of retrograde flow, bleeding, stroke and an inflammatory response. This will be the first FDA IDE study to capture the adverse events of ECMO for cardiogenic shock patients. ECMO for oxygenation therapy will be allowed in both arms as an escalation option.
The primary endpoint of RECOVER IV is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, days alive out of the hospital at six months, recovery of left ventricular (LV) function, need for durable ventricular assist device (VAD) or heart transplant and health-related quality of life as measured by responses to the Kansas City Cardiomyopathy Questionnaire (KCCQ) at one year. Abiomed’s goal in conducting the trial is to achieve a global AMI cardiogenic shock Class I guideline recommendation for Impella and related best practice protocols, including implantation pre-PCI.