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Competing Interests: Disclosures Dr Grinstein is a speaker for Abbott, Medtronic, CH Biomedical, and Abiomed. Dr Cowger is a consultant, speaker, and is on the advisory board for Abbott and Medtronic. She is on the steering committee for Nuwellis and Endotronix. She is a speaker for Zoll. She is a consultant and owns stock options for Aortix. She is on the data safety monitoring board for Bivacor. She is also on the JHLT editorial board. Dr Tedford reports no direct conflicts of interest related to this article. He reports general disclosures to include consulting relationships with Medtronic, Abbott, Aria CV Inc, Acceleron/Merck, Alleviant, CareDx, Cytokinetics, Itamar, Edwards LifeSciences, Eidos Therapeutics, Lexicon Pharmaceuticals, and Gradient. Dr Tedford is the national principal investigator for the RIGHT-FLOW clinical trial (Edwards), serves on the steering committee for Merck and Abbott as well as a research advisory board for Abiomed. He also does hemodynamic core laboratory work for Merck. The other authors report no conflicts.

Background: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery., Methods: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial., Results: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support., Conclusions: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.