Impella rp post approval study: First multi-center, prospective post market approval results for the impella rp in patients with right ventricular failure
Anderson M, Morris L, Tang D, Batsides G, Kirlane A, Hanson I, Meraj P, Kapur N, O'Neill W. Impella rp post approval study: First multi-center, prospective post market approval results for the impella rp in patients with right ventricular failure. J Heart Lung Transplant. Apr 2017;36(4):S64-S65.
J Heart Lung Transplant
Summary of Objectives: Right Ventricular (RV) failure increases morbidity and mortality and contributes to prolonged hospital lengths of stay and higher costs of care. The primary objective for this study is to assess the outcomes of the post market approval use of the Impella RP , the first percutaneous right ventricular support FDA approved device for patients with RV failure that require hemodynamic support. Methods: The Impella RP post approval study is a prospective, single arm multi-center study planning to enroll 30 patients at 15 sites. Patients that develop acute RV failure following LVAD implantation, post myocardial infarction or post open heart surgery (including post heart transplant) and have BSA ≥ 1.5 m2 are included in the trial. Major exclusion criteria are presence of mural thrombus into the right heart or the inferior vena cava, presence of mechanical valves, or severe stenosis or regurgitation of the tricuspid or pulmonic valves. Patient baseline and procedural characteristics, hemodynamic parameters, hospital stay data and patient outcomes to 180 days are collected. Major adverse events are adjudicated by an independent clinical events committee. Endpoints: The primary study endpoint is the survival rate at 30 days post device explant or at hospital discharge (whichever is longer). Secondary endpoints are major adverse events such as death, major bleeding, pulmonary embolism, and hemolysis. Improvement and hemodynamic parameters and use of inotropes are also evaluated. The outcome trends in the post approval study will be benchmarked against the original Recover Right study and the pooled data from all the Impella RP clinical studies will be presented at the meeting.