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 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT00589303
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 65 years
* Paroxysmal, persistent, or permanent atrial fibrillation
* Index event of atrial fibrillation is documented on electrocardiogram or rhythm strip. Atrial fibrillation must be the qualifying event. Atrial flutter can have been present in the past, but it must not be considered the index arrhythmia.
* Paroxysmal atrial fibrillation episodes must be recurrent (two or more episodes in the past 6 months). At least one of the paroxysmal episodes must be "sustained", defined as lasting greater than 1 hour documented by a Holter monitor or by history in conjunction with an ECG or a rhythm strip.
* At least one attempt of unsuccessful drug therapy, either for rate, for rhythm, or for rate-and-rhythm control.
* Symptoms related to atrial fibrillation within the last 6 months
* Eligible for long-term treatment with both treatment strategies
* Must provide informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and be willing to comply with follow-up requirements.
Exclusion Criteria:
* Reversible causes of atrial fibrillation
* On heart transplant list
* Familial cardiac conditions with increased risk of sudden death
* Asymptomatic
* Medical condition limiting expected survival to be less than one year
* Contraindications to anticoagulation
* Pre-existing implanted pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device.
* Pre-existing indication for permanent pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device
* More than one attempt of drug therapy for rate, for rhythm, or for rate-and-rhythm control
* Planned major surgery within the next six months, including thoracic surgery
* Disability that would preclude collection of study data or have co-morbidity that would contraindicate device implantation
* Participated in another clinical trial within the previous 30 days using a therapeutic modality which could have potential residual effects that might confound the results of this pilot study
* Unable to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00589303
Study Brief:
Protocol Section:
NCT00589303