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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT06182566
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet all of the following criteria:
* Be \>18 years of age
* Provide signed written Informed Consent
* Persistent or longstanding persistent AF
* Heart failure with LV systolic dysfunction (defined as EF\<40%) and prior hospitalization for heart failure in the preceding 12 months (randomization will account for 2 strata \>30% vs \<30% to ensure balanced enrollment)
* Moderate or severe left atrial enlargement (Left atrial diameter\>45 mm and not exceeding 60 mm; or indexed LA volume \>40 ml/m2 and not exceeding 110 ml/ m2)
* Ability to complete 6 minute walk test
* Negative pregnancy test for female patients of child bearing potential.
* Be eligible for ablation and anti-arrhythmic drugs
Exclusion Criteria:
Subjects must meet none of the criteria:
* Very severe left atrial enlargement with diameter \>60 mm or indexed LA Volume \>110 mL/m2
* Stroke or myocardial infarction within the preceding 3 months
* Reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
* Presently with Valvular Heart disease requiring surgical intervention
* Presently with coronary artery disease requiring surgical or percutaneous intervention
* Early Post-operative AF (within three months of surgery)
* History of AVN ablation
* Liver Failure
* Renal Failure requiring dialysis
* Social factors that would preclude follow up or make compliance difficult.
* Contraindication to the use of appropriate anticoagulation therapy
* Enrollment in another investigational drug or device study.
* Patients with severe pulmonary disease
* Documented intra-atrial thrombus, tumor, or another structural abnormality which precludes ablation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06182566
Study Brief:
Protocol Section:
NCT06182566