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

NCT00562432 | Completed

• 2 other identifiers: SYM-07-001EudraCT Number 2007-006728-37
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; CABG; ganglionated plexi

Outcome Measures

Primary Outcomes (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.

  90 days

Secondary Outcomes (1)

• freedom from atrial fibrillation

  5 days

Study Arms (2)

Plexisyl-AF

EXPERIMENTAL

Plexisyl-AF implants

Device: Plexisyl-AF

No Treatment

SHAM COMPARATOR

Surgery without experimental treatment

Device: Plexisyl-AF; Other: No Treatment

Interventions

Plexisyl-AF DEVICE

Plexisyl-AF implants

Also known as: Standard surgery without device

No Treatment; Plexisyl-AF

No Treatment OTHER

CABG without the experimental treatment

Also known as: surgery without device

No Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LoneStar Heart, Inc.: lead

Study Sites (3)

Heart Center Dresden

Dresden, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Deutsches Herzzentrum München

Munich, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Bauernschmitt, MD

  Munich Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 22, 2007
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 10, 2011

Record last verified: 2008-09

Locations

DE (3)