Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598280
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHAzAM-AF
Brief Summary:
Prospective randomized controlled multicentre study to compare the safety and efficacy of a Same Day Discharge SDD protocol in combination with a Perclose ProStyle PPS ProGlide PPG suture mediated vascular closure device to the current gold standard an overnight stay ONS protocol associated with manual compression figure-of-eight suture for the patients receiving interventional pulmonary vein isolation PVI
Detailed Description:
The aim of the study is to prove that the use of a SDD protocol does not lead to a higher rate of adverse events minor and major unplanned medical visits emergency department or outpatients clinic and unplanned readmissions while substantially reducing the costs associated with the medical care and increasing the comfort of the patients on a period of 30 days when compared to ONS and manual compression figure-of-eight suture Moreover the safety efficiency and feasibility of the SDD protocol should be proven during a follow-up FU period of 12 months The definition of endpoints will be trained in all participating study sites to preserve consistency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None