Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04443218
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2020-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Edwards PASCAL Transcatheter Valve Repair System Registry
Sponsor:
Edwards Lifesciences
Organization:
Study Overview
Official Title:
Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System
Status:
COMPLETED
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:
PASCALRegistry
Brief Summary:
This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
Detailed Description:
Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.
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?: