Text Size

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

This study has been completed.
Sponsor:
Information provided by:
LoneStar Heart, Inc.
ClinicalTrials.gov Identifier:
NCT00562432
First received: November 20, 2007
Last updated: March 8, 2011
Last verified: September 2008
History of Changes
  Purpose

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
Atrial Fibrillation
 Device: Plexisyl-AF
Other: No Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LoneStar Heart, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • freedom from atrial fibrillation [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562432

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

No publications provided

Responsible Party: Andy Hinson, VP Clinical & Regulatory Affairs, LoneStar Heart, Inc
ClinicalTrials.gov Identifier: NCT00562432     History of Changes
Other Study ID Numbers: SYM-07-001, EudraCT Number 2007-006728-37
Study First Received: November 20, 2007
Last Updated: March 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on June 17, 2013