Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT04782232
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Berlin Heart GmbH
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RegiVe
Brief Summary:
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.
Detailed Description:
The registry study has an observational, prospective, international, multi-center, non-randomized design.
The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: