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COMPANY

Berlin Heart

berlinheart.com ↗

FDA-cleared device company

Profile checked Oct 10, 2026

Keywords: Heart Failure Ventricular Dysfunction Cardiomyopathies Heart Diseases Cardiovascular Diseases Congenital Heart Disease Univentricular Heart Left Ventricular Dysfunction Right Ventricular Dysfunction Severe Isolated Left Ventricular Dysfunction Severe Biventricular Dysfunction EXCOR Pediatric EXCOR Active Driving System for Pediatric VAD

7Trials (company is sponsor)

Timeline

  1. Trial start Not phased (device or behavioral study): EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study source ↗
  2. Trial start —: Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart source ↗
  3. Trial start —: The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support source ↗
  4. Trial start —: Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation. source ↗
  5. Trial start —: Berlin Heart EXCOR Pediatric Post Approval Study source ↗
  6. Trial start Not phased (device or behavioral study): Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 7

RecordTitlePhaseStatusStartPrimary completion
NCT05610787EXCOR Active Driving System for the EXCOR Pediatric VAD IDE StudyNot phased (device or behavioral study)Enrolling by invitationNov 14, 2022Nov 10, 2023 (actual)
NCT04782232Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right HeartNot listedRecruitingJun 1, 20212027-09 (estimated)
NCT04634708The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device SupportNot listedCompletedNov 1, 2020Sep 15, 2022 (actual)
NCT03701997Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.Not listedUnknown status (ClinicalTrials.gov)Oct 15, 20182021-12 (estimated)
NCT00583661Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist DeviceNot phased (device or behavioral study)Completed2007-052010-09 (actual)
NCT01674699Berlin Heart EXCOR Pediatric Post Approval StudyNot listedUnknown status (ClinicalTrials.gov)2012-082015-06 (estimated)
NCT01242891Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access ProtocolNot listedApproved for marketingNot listedNot listed
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