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Sponsored by: |
Symphony Medical, Inc. |
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Information provided by: | CardioPolymers, Inc. |
ClinicalTrials.gov Identifier: | NCT00562432 |
The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct application to the cardiac fat pads in patients undergoing coronary artery bypass grafting. Secondary goals of the study are to assess the potential response of Plexisyl-AF to reduce the occurrence of postoperative atrial fibrillation and assess the performance of the electrostimulator device to confirm the location of the epicardial fat pads (nerves). The occurrence of postoperative atrial fibrillation will be monitored by continuous cardiac monitoring.
Condition | Intervention |
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Atrial Fibrillation |
Device: Plexisyl-AF Other: No Treatment |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
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) |
Enrollment: | 32 |
Study Start Date: | February 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Plexisyl-AF: Experimental
Plexisyl-AF implants
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Device: Plexisyl-AF
Plexisyl-AF implants
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No Treatment: Sham Comparator
Surgery without experimental treatment
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Device: Plexisyl-AF
Plexisyl-AF implants
Other: No Treatment
CABG without the experimental treatment
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Germany | |
Herzzentrum Leipzig GmbH | |
Leipzig, Germany | |
Heart Center Dresden | |
Dresden, Germany | |
Deutsches Herzzentrum München | |
Munich, Germany |
Principal Investigator: | Robert Bauernschmitt, MD | Munich Heart Center |
Responsible Party: | Symphony Medical ( Andy Hinson, VP Clinical & Regulatory Affairs ) |
Study ID Numbers: | SYM-07-001, EudraCT Number 2007-006728-37 |
Study First Received: | November 20, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00562432 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
atrial fibrillation CABG ganglionated plexi |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |