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

March 8, 2011 updated by: LoneStar Heart, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany
        • Heart Center Dresden
      • Leipzig, Germany
        • Herzzentrum Leipzig GmbH
      • Munich, Germany
        • Deutsches Herzzentrum München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
freedom from atrial fibrillation
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LoneStar Heart, Inc.

Investigators

  • Principal Investigator: Robert Bauernschmitt, MD, Munich Heart Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYM-07-001
  • EudraCT Number 2007-006728-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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