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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07320768
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years.
* Patients with persistent atrial fibrillation undergoing first-time catheter ablation (defined as any episode lasting ≥7 days).
* Symptomatic atrial fibrillation refractory to or intolerant of at least one class I or III antiarrhythmic drug and scheduled for guideline-directed catheter ablation.
* Able to understand the study purpose, voluntarily participate, and sign the written informed consent form.
Exclusion Criteria:
* Presence of advanced structural heart disease.
* Life expectancy \< 12 months.
* Blood pressure \< 90/60 mmHg.
* Pregnant or lactating women.
* Anatomical abnormalities of the renal arteries unsuitable for treatment as determined by pre-procedural renal CTA.
* History of renal artery intervention, impaired renal function with estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m² (calculated by the MDRD equation).
* Secondary atrial fibrillation due to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes.
* Contraindication to pulsed-field ablation (e.g., left atrial thrombus, prior atrial septal defect occluder implantation, or permanent metallic implant in the left atrium) or to anticoagulation therapy.
* Known inability to obtain vascular access or contraindication to femoral venous puncture.
* Heart failure with left ventricular ejection fraction \< 30% documented by transthoracic echocardiography within 3 months before ablation.
* Patients with current or anticipated need for pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT), or prior transseptal closure with occluder device for atrial septal defect or patent foramen ovale.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07320768
Study Brief:
Protocol Section:
NCT07320768