CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 439 enrolled
Drug / intervention
CorMatrix ECM for Pericardial Closuredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01247974
NCT01247974N/ACompleted
CompareCT.gov

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

Elutia Inc.·interventional·Posted Nov 25, 2010·Updated Jul 27, 2023

In Brief

A clinical study evaluating CorMatrix ECM for Pericardial Closure for Atrial Fibrillation New Onset. Completed, enrolled 439 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation New Onset
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.6 years ago

Interventions

CorMatrix ECM for Pericardial Closuredevice

Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure