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Evaluation Of New Onset Postoperative Atrial Fibrillation

NCT01247974 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2023-07-27

Study results available
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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.

Conditions

  • Atrial Fibrillation New Onset

Interventions

DEVICE

CorMatrix ECM for Pericardial Closure

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

Sponsors & Collaborators

  • Elutia Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Gerdisch, M.D. · St. Francis Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01247974 on ClinicalTrials.gov