A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study

Abstract

This is a single-arm, non-randomized study designed to assess the preliminary safety and clinical performance of a novel ambulatory counterpulsation device. The device is an intra-aortic, counterpulsation blood pump delivered via axillary artery. The system includes a skin interface device facilitating patient ambulation and an external, portable drive unit allowing increased mobility and independence. This study will assess potential benefits to patients who have advanced heart failure and require additional circulatory support. This study will evaluate human factors, the clinical safety of the device, device failures, whether the device performs its intended purpose, patient characteristics that may impact device performance, and device use outside of the hospital. Following a First-in-Human study of 14 patients, this feasibility study will enroll up to 86 implanted patients in up to 20 investigational sites for a total of 100 patients on device. To date, 71 of 100 patients have been implanted across 14 of 16 participating institutions. The primary endpoint of this study is to assess survival to transplant or stroke-free survival at 30 days. The following secondary endpoints will also be evaluated at 30 days: number of patients who deteriorate requiring escalation of inotropic support and/or additional mechanical circulatory support; incidence of serious device-related adverse events; incidence of procedure-related adverse events; incidence of all adverse events; change in NYHA class from baseline; change in quality of life from baseline as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) - global assessment; change in Seattle Heart Failure Model Prognosis Score; change in six minute walk test and two minute step test from baseline. Subjects supported with the device past 30 days will continue to be followed and evaluated in the study until transplantation, device explant, alternative mechanical circulatory support or death. A Pivotal Trial with this device is expected to begin by the second quarter of 2020.