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:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT06988202
Eligibility Criteria:
Inclusion Criteria
* Age ≥ 18 years on date of consent
* One prior PVI ablation procedure \> 3 months prior for persistent AF
* Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
* Eligible for repeat ablation procedure
* Willingness to comply with all post-procedural follow-up requirements and to sign informed consent
Exclusion Criteria
* Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus)
* Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
* Prior surgical ablation for AF
* Contraindication to systematic anticoagulation
* LA diameter on echocardiogram \> 6.0 cms
* LV ejection fraction \< 35%
* NYHA class III-IV congestive heart failure
* Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date
* Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
* Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
* Prior valve replacement with mechanical prosthesis
* Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date
* Stroke within 3 calendar months prior to consent date
* Any medical condition likely to limit survival to \< 1 year
* Renal failure requiring dialysis at time of consent
* Pregnancy
* History of non-compliance to medical therapy
* Participation in other clinical trials (observational/lead registries are allowed) without approval from the CCRC
* Inability or unwillingness to provide informed consent
* Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
* Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06988202
Study Brief:
Protocol Section:
NCT06988202