Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-30 @ 11:43 AM
Study NCT ID:
NCT05142293
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
One Day Implantation Program for Heart Failure Patients Implanted With BIOTRONIK Cardiac Resynchronization Therapy Pacemakers
Status:
RECRUITING
Status Verified Date:
2024-10
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:
OEDIPE-CRT-P
Brief Summary:
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
Detailed Description:
The objective of the study is to show in the French centers selected for the same-day organization that a same-day CRT-P implantation is safe, feasible, and associated with significant cost-saving and a minimum conversion rate to full hospitalization by comparing outcomes with patients routinely hospitalized for at least one night. The medical economic evaluation will be based on the SNDS (National Health Data System) analysis.
Study Oversight
Has Oversight DMC:
True
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?: