Single-arm study for assessment of safety and effectiveness of the extracorporeal continuous-flow ventricular assist device (BR16010) use as a bridge-to-decision therapy for severe heart failure or refractory cardiogenic shock

Phase 3

• Conditions: Subjects with severe heart failure or cardiogenic shock refractory to optimal medical management, standard surgical procedures, or mechanical circulatory supports [e.g. intra-aortic balloon pumping (IABP), ventriculo-arterial bypass (VA bypass) and percutaneous cardiopulmonary support (PCPS))]

• Registration Number: JPRN-UMIN000029065
• Lead Sponsor: ational Cerebral and Cardiovascular Center

Brief Summary

ine patients were enrolled. Six had INTERMACS profile 1, and 3 were profile 2. Eight patients received LVAD. One patient with fulminant myocarditis received biventricular support using the novel VAD system. 3 patients were weaned from VAD and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-20
• Study Completion: 2018-05-07
• Results First Posted: 2020-05-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

1)Unfavorable or technically-challenging cardiac anatomy 2)Evidence of irreversible hepatic disease (except when the primary investigator deems it as a sign of acute heart failure) 3)Evidence of irreversible renal disease (except when the primary investigator deems it as a sign of acute heart failure) 4)Evidence of irreversible intrinsic respiratory disease (e.g. chronic pulmonary disease, acute respiratory distress syndrome) which needs mechanical respiratory support (except when the primary investigator deems it as a sign of acute heart failure) 5)Contraindicated for anticoagulation 6)Difficulty of 30-day observation is anticipated 7)Pregnant, or suspected pregnant at time of study entry 8)Participating in another clinical trial at time of study entry 9)Deemed unsuitable by the primary investigator for other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Device-related serious adverse events and complications during device support Effectiveness: For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other VAD during 30 days after implantation For right ventricular assistance, withdrawal of trial device due to right ventricular function recovery within 30 days after implantation

Secondary Outcome Measures

Name	Time	Method
1) Changes in brain natriuretic peptide (BNP) levels (7 days after implantation of a trial device and the day of withdrawal of a trial device) 2) Period of mechanical ventricular support 3) Changes in left ventricular ejection fraction (LVEF) (7 days after implantation of a trial device and the day of withdrawal of a trial device) 4) Changes in left ventricular diastolic dimension (LVDd)(7 days after implantation of a trial device and the day of withdrawal of a trial device)