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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT02710669
Eligibility Criteria:
Inclusion:
1. History of atrial fibrillation
2. Greater than or equal to 18 years of age
3. Scheduled to undergo an atrial fibrillation ablation procedure
4. Able to provide written informed consent
Exclusion:
1. Long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode)
2. Is in atrial fibrillation or atrial flutter the morning of the ablation procedure
3. The presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator
1. sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia
2. sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration
3. right bundle branch block, left bundle branch block, or bifascicular block
4. PR-interval \> 280ms, or history of 2nd or 3rd degree atrioventricular block
4. Concomitant use of CYP3A4 and CYP2D6 inhibitors
5. Previous surgical or catheter ablation for atrial fibrillation or Cox-Maze procedure
6. Amiodarone use within 3 months prior to enrollment
7. Antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation
8. Expected life span \< 1 year
9. Creatinine clearance \<30 mL/min
10. Reversible cause of atrial fibrillation (ie. thyrotoxicosis)
11. Unrevascularized coronary artery disease
12. Canadian class IV angina
13. Left ventricular ejection fraction \<40%
14. New York Heart Association Class III or IV symptoms
15. Previous heart transplantation
16. Planned heart transplantation or ventricular assist device
17. Cardiac/thoracic surgery \<6 months prior to enrollment
18. Severe asthma or chronic obstructive pulmonary disease
19. Breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02710669
Study Brief:
Protocol Section:
NCT02710669