A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
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|ClinicalTrials.gov Identifier: NCT00562432|
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : March 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Plexisyl-AF Other: No Treatment||Not Applicable|
The purpose of this study is to investigate a non-surgical and non-destructive approach to providing a temporary, protective parasympathectomy as a means to reducing postoperative atrial fibrillation following cardiac surgery. Applications of Plexisyl-AF will be placed in the cardiac fat pads as a means for creating a "non-destructive" cardiac denervation.
This is a randomized assessment to demonstrate the safety of Plexisyl-AF in patients undergoing open heart surgery. Eligible patients will be those submitted to undergo open-chest CABG. Patients will receive Plexisyl-AF, administered via direct application to the SA nodal and AV nodal epicardial fat pads during the surgical procedure.
Patients will be monitored for the occurrence of atrial fibrillation via the use of continuous cardiac monitoring for a period of 120 hours following surgery. Patients will return the clinic for brief follow-up, including electrocardiographic recordings, 10 days, 30 days and 90 days after the date of surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF Administered to the Epicardial Fat Pads in Patients Undergoing Open-chest Coronary Artery Bypass Grafting (CABG)|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Other Name: Standard surgery without device
Sham Comparator: No Treatment
Surgery without experimental treatment
Other Name: Standard surgery without deviceOther: No Treatment
CABG without the experimental treatment
Other Name: surgery without device
- Safety and tolerability of Plexisyl-AF administered by direct injection to the epicardial fat pads, evaluated through analysis of freedom from adverse experiences, clinical laboratory tests, electrocardiogram and physical examinations. [ Time Frame: 90 days ]
- freedom from atrial fibrillation [ Time Frame: 5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562432
|Heart Center Dresden|
|Herzzentrum Leipzig GmbH|
|Deutsches Herzzentrum München|
|Principal Investigator:||Robert Bauernschmitt, MD||Munich Heart Center|