Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT00562432
Eligibility 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00562432
Study Brief:
Protocol Section:
NCT00562432