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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT01248156
Eligibility Criteria:
INCLUSION CRITERIA for STUDY SUBJECTS:
* patients undergoing electrophysiology study (EPS) for ablation of (a) paroxysmal AF (non-rheumatic) whose AF episodes self-terminate in \< 7 days, or (b) persistent AF (non-rheumatic) whose AF episodes last \>or= 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
* AF patients must have failed \>or= 1 anti-arrhythmic drug
INCLUSION CRITERIA for ALL SUBJECTS:
* will have a full evaluation focusing on diabetes mellitus, hypertension, coronary disease, left ventricular ejection fraction (LVEF). We will document whether AF relates to times of vagal activity (meals or sleep) or exercise. We will record the use of drugs affecting the renin-aldosterone-angiotensin system (RAAS) and statins, that may protect against atrial fibrosis and AF. We will document serum potassium level, since slight elevations slow CV in vitro. We will record 12-lead ECG and echocardiography for left atrial diameter, and stress test and/or coronary angiography if indicated.
* will have event monitor recordings with daily transmissions for at least one week to document AF burden (study subjects) or exclude AF (control subjects).
* must have with-held amiodarone for \> 30 days and other anti-arrhythmic drugs for \> 5 half-lives.
EXCLUSION CRITERIA FOR ALL SUBJECTS:
* active coronary ischemia in the past year, since the protocol uses isoproterenol
* rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk
* prior ablation or cardiac surgery, that alters atrial electrophysiology
* LA clot or dense contrast on TEE
* deranged serum electrolytes, and K+ outside 4.0-5.0 mmol/l
* left atrial diameter \> 60 mm
* LVEF \< 40% or New York Heart Association heart failure \> Class II, to exclude distinct, heart-failure related remodeling
* thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
* pregnancy, to minimize fluoroscopy. As part of routine clinical care, all female patients of childbearing age receive a ß-HCG pregnancy test. Any who test positive will not be included in the research study
* inability or unwillingness to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01248156
Study Brief:
Protocol Section:
NCT01248156