Back to resultsA Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Plexisyl-AF
No Treatment
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, CABG, ganglionated plexi
Eligibility Criteria
Inclusion Criteria
- The patients must be able and willing to give written informed consent.
- 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.
- 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.
- 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
- Emergent open heart surgery.
- Patients scheduled to undergo mitral valve surgery, aortic, pulmonic or tricuspid valve replacements, and replacement or reconstruction of the aorta.
- Patients who have undergone a previous open chest CABG procedure.
- Previous history of atrial fibrillation or flutter.
- Patient with clinical hypothyroidism or hyperthyroidism.
- 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.
- First-degree or higher degrees of atrioventricular (AV) block (PR interval >210 msec)
- An ejection fraction of less than 30%.
- Clinically active congestive heart failure.
- Serum creatinine > 2.0 mg/dL or currently receiving dialysis.
- 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).
- 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.
- Any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.
Sites / Locations
- Heart Center Dresden
- Herzzentrum Leipzig GmbH
- Deutsches Herzzentrum München
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Plexisyl-AF
No Treatment
Arm Description
Plexisyl-AF implants
Surgery without experimental treatment
Outcomes
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.
Secondary Outcome Measures
freedom from atrial fibrillation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00562432
Brief Title
A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
LoneStar Heart, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, CABG, ganglionated plexi
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plexisyl-AF
Arm Type
Experimental
Arm Description
Plexisyl-AF implants
Arm Title
No Treatment
Arm Type
Sham Comparator
Arm Description
Surgery without experimental treatment
Intervention Type
Device
Intervention Name(s)
Plexisyl-AF
Other Intervention Name(s)
Standard surgery without device
Intervention Description
Plexisyl-AF implants
Intervention Type
Other
Intervention Name(s)
No Treatment
Other Intervention Name(s)
surgery without device
Intervention Description
CABG without the experimental treatment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
freedom from atrial fibrillation
Time Frame
5 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
The patients must be able and willing to give written informed consent.
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.
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.
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
Emergent open heart surgery.
Patients scheduled to undergo mitral valve surgery, aortic, pulmonic or tricuspid valve replacements, and replacement or reconstruction of the aorta.
Patients who have undergone a previous open chest CABG procedure.
Previous history of atrial fibrillation or flutter.
Patient with clinical hypothyroidism or hyperthyroidism.
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.
First-degree or higher degrees of atrioventricular (AV) block (PR interval >210 msec)
An ejection fraction of less than 30%.
Clinically active congestive heart failure.
Serum creatinine > 2.0 mg/dL or currently receiving dialysis.
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).
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.
Any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bauernschmitt, MD
Organizational Affiliation
Munich Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Dresden
City
Dresden
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
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