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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

Study acronym: RegiVe
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Nov 1, 2024 to Sep 2027v5
  2. Minor 2 versions Re-verified since Feb 9, 2023, no change to tracked fieldsv3-v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2021 to Jun 1, 2021
    • Study sites: 0 to 1
    • Primary and study completion dates: Jul 1, 2024 to Nov 1, 2024
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.
Trial Details
NCT Number NCT04782232
Lead Sponsor Berlin Heart GmbH
Conditions
(from sponsor)
Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
Related terms Cardiovascular Diseases, Heart Diseases, Heart Failure, Univentricular Heart, Ventricular Dysfunction
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov