A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562432
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : March 10, 2011
Information provided by:
LoneStar Heart, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Device: Plexisyl-AF Other: No Treatment Not Applicable

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Plexisyl-AF
Plexisyl-AF implants
Device: Plexisyl-AF
Plexisyl-AF implants
Other Name: Standard surgery without device
Sham Comparator: No Treatment
Surgery without experimental treatment
Device: Plexisyl-AF
Plexisyl-AF implants
Other Name: Standard surgery without device
Other: No Treatment
CABG without the experimental treatment
Other Name: surgery without device

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. freedom from atrial fibrillation [ Time Frame: 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. The patients must be able and willing to give written informed consent.
  2. The patients will be adult (age ≥ 18 years and </= 70 years) males or females who are scheduled to undergo on-pump open-chest coronary artery bypass grafting surgery of two (2) or more arteries.
  3. The patients should be effectively treated prior to enrollment with an appropriate medical regimen (such as aspirin, ß-blockers, nitrates, and ACE inhibitors). Changes to medications after enrollment should be avoided.
  4. If female, the patients must be (a) post-menopausal, (b) surgically sterile or (c) using adequate birth control and have a negative pregnancy test within 7 days prior to administration of device.

Exclusion Criteria

  1. Emergent open heart surgery.
  2. Patients scheduled to undergo mitral valve surgery, aortic, pulmonic or tricuspid valve replacements, and replacement or reconstruction of the aorta.
  3. Patients who have undergone a previous open chest CABG procedure.
  4. Previous history of atrial fibrillation or flutter.
  5. Patient with clinical hypothyroidism or hyperthyroidism.
  6. Prophylactic medication for the prevention of atrial fibrillation or current use of an antiarrhythmic medication. Patients who have been receiving beta-blockers and calcium channel blockers before screening may continue taking the medication.
  7. First-degree or higher degrees of atrioventricular (AV) block (PR interval >210 msec)
  8. An ejection fraction of less than 30%.
  9. Clinically active congestive heart failure.
  10. Serum creatinine > 2.0 mg/dL or currently receiving dialysis.
  11. Clinically significant liver enzyme abnormalities (i.e., AST or ALT more than two times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal).
  12. The patients will not be receiving concurrently an investigational product in another clinical trial or have received an investigational product in another clinical trial in the 30 days prior to enrollment.
  13. Any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00562432

Heart Center Dresden
Dresden, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Deutsches Herzzentrum München
Munich, Germany
Sponsors and Collaborators
LoneStar Heart, Inc.
Principal Investigator: Robert Bauernschmitt, MD Munich Heart Center

Responsible Party: Andy Hinson, VP Clinical & Regulatory Affairs, LoneStar Heart, Inc Identifier: NCT00562432     History of Changes
Other Study ID Numbers: SYM-07-001
EudraCT Number 2007-006728-37
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: September 2008

Keywords provided by LoneStar Heart, Inc.:
atrial fibrillation
ganglionated plexi

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes