Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06267612
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corheart 6 LVAS Long-term Follow-up Study
Sponsor:
Nanjing First Hospital, Nanjing Medical University
Organization:
Study Overview
Official Title:
Long-term Follow-up Study of Corheart 6 Left Ventricular Assist System as Treatment of Patients With Advanced Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.
The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: