NCT01247974

Evaluation Of New Onset Postoperative Atrial Fibrillation

Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM® for Pericardial Closure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Elutia Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites in the U.S.

Detailed description

The objective of this prospective clinical trial is to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures as compared to subjects who did not undergo pericardial closure. Safety will be established by demonstrating that the composite clinical event rate for the ECM treatment group is not worse than the control group that did not undergo pericardial closure. The efficacy will be established by demonstrating a reduced incidence of new onset postoperative atrial fibrillation in the ECM treatment group as compared to the control group.

Conditions

• Atrial Fibrillation New Onset

Interventions

Type	Name	Description
DEVICE	CorMatrix ECM for Pericardial Closure	Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-11-25
• Last updated: 2023-07-27
• Results posted: 2015-09-16

Locations

16 sites across 1 country: United States