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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT00514735
Eligibility Criteria:
INCLUSION CRITERIA:
* History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
* Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
* Age between 18 and 70 years
* Failure of at least one Class I or III rhythm control drug
* Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
EXCLUSION CRITERIA:
* Structural heart disease of clinical significance including:
* Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
* Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction \<40% measured by acceptable cardiac testing
* Left atrial diameter \>55 mm
* Moderate to severe mitral or aortic valvular heart disease
* Stable/unstable angina or ongoing myocardial ischemia
* Myocardial infarction (MI) within 3 months of enrollment
* Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
* Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
* Hypertrophic cardiomyopathy (left ventricular septal wall thickness \>1.5 cm)
* Pulmonary hypertension (mean or systolic pulmonary artery pressure \>50 mm Hg on Doppler echo)
* Any prior ablation for atrial fibrillation
* Enrollment in any other ongoing arrhythmia study
* Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
* Active infection or sepsis
* Any history of cerebral vascular disease including stroke or transient ischemic attacks
* Pregnancy or lactation
* Left atrial thrombus at the time of ablation
* Untreatable allergy to contrast media
* Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
* History of blood clotting (bleeding or thrombotic) abnormalities
* Known sensitivities to heparin or warfarin
* Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) \<1)
* Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00514735
Study Brief:
Protocol Section:
NCT00514735