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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT00744835
Eligibility Criteria:
Inclusion Criteria:
* History of symptomatic permanent atrial fibrillation
* Age between 18 and 70
* 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
* Any prior ablation for atrial fibrillation
* Prior ablation for arrhythmias other than AF within the past three months
* Enrollment in any other ongoing arrhythmia study protocol
* Any ventricular tachyarrhythmias 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 TIAs
* Pregnancy or lactation
* Left atrial thrombus at the time of ablation
* Untreatable allergy to contrast media
* Any diagnosis of AF 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 COPD (identified by an FEV1 \< 1)
* Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00744835
Study Brief:
Protocol Section:
NCT00744835