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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02821351
Eligibility Criteria:
Study Inclusion Criteria
Subjects for this study must meet ALL of the following criteria:
* Suitable candidate for intra-cardiac mapping and ablation for arrhythmias.
* History of recurrent symptomatic PAF1 WITH ≥2 episodes reported within the 365 days (12) months prior to enrollment.
* At least one episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
* Refractory to at least one Class I - IV anti-arrhythmic drug (AAD)
* Eighteen (18) years of age or above
* Competent and willing to provide written informed consent to participate in the study and agree to comply with the follow-up visits and evaluation.
Study Exclusion Criteria
Candidates will be excluded from the study if any of the following conditions apply:
* Previous left atrial ablation procedure
* Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
* Known severe cerebrovascular disease or history of cerebrovascular event (within 1 month)
* Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. This is calculated as follows for males:
GFR = (140 - age) x weight x .85 (for females) PCr x 72 where age is specified in years, weight in kg, and PCr is Serum Creatinine in mg/dL Female GFR is reduced by 15% of the above calculated value for males.
* Active gastrointestinal bleeding
* Active infection or fever (\> 100.5 F/38 C)
* Sepsis
* Cardiac surgery within the past two months
* Short life expectancy (\< 1yr) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease
* Significant anemia (hemoglobin \< 8.0 mg/dL)
* Severe uncontrolled systemic hypertension (systolic press. \> 240 mm Hg within the last 30 days)
* Documented anaphylaxis during previous exposure to angiographic contrast media
* Uncontrolled congestive heart failure (NYHA Class III or IV)
* Unstable angina or acute myocardial infarction within the past three months
* Bleeding, clotting disorders, or known thrombosis
* Severe Peripheral vascular disease
* Uncontrolled diabetes
* Rheumatic heart disease
* Heart valve replacement
* Mitral clip (Evalve)
* Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study
* Active participation in another investigational protocol currently or the last 30 days
* Unable or unwilling to take anti-coagulants
* Unwilling or unable to comply with any protocol or follow up requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02821351
Study Brief:
Protocol Section:
NCT02821351