Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903222
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-06-05
Brief Title:
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery - Extended Follow-Up PALACS-EF Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
PALACS-EF
Brief Summary:
The purpose of the Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery PALACS NCT02875405 trial was to determine if performing posterior left pericardiotomy at the time of cardiac surgery prevents atrial fibrillation after cardiac surgery The purpose of the Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery-Extended Follow-Up PALACS-EF study is to evaluate the effect of posterior left pericardiotomy on 5-year clinical outcomes
Detailed Description:
Post-operative atrial fibrillation POAF is a common complication of cardiac surgery which is observed in 30-40 of patients POAF has also been associated with stroke systemic embolism or cardiac failure during the years after surgery Several strategies aimed at reducing the incidence of POAF have been investigated including beta-blockers amiodarone and statins with unsatisfactory results In the randomized prospective clinical trial the PALACS trial 420 patients were randomized either to the intervention group which received left posterior pericardiotomy at time of cardiac surgery or to the control group which did not receive posterior left pericardiotomy at time of cardiac surgery Posterior left pericardiotomy was associated with a reduction in the incidence of POAF after surgery but not with improvement in 30-day patient outcomes
This non-interventional prospective study is an extension follow-up study PALACS-EF of all patients who were enrolled in the original PALACS trial It is designed to evaluate differences in clinical outcomes between patients who received posterior left pericardiotomy intervention versus those who did not control at median follow-up of 5 years
This non-interventional prospective study is an extension follow-up study PALACS-EF of all patients who were enrolled in the original PALACS trial It is designed to evaluate differences in clinical outcomes between patients who received posterior left pericardiotomy intervention versus those who did not control at median follow-up of 5 years
Study Oversight
Has Oversight DMC:
None
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?:
None