Status:
NOT_YET_RECRUITING
PVI Alone vs PVI With Posterior Wall Isolation for Pulse-Field Ablation in Persistent AF
Lead Sponsor:
Ewha Womans University Mokdong Hospital
Collaborating Sponsors:
Ewha Womans University Seoul Hospital
Korea University Anam Hospital
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To date, no optimal treatment has been established to improve outcomes in patients with persistent atrial fibrillation. The safety and efficacy of pulsed-field ablation (PFA) have been demonstrated in...
Detailed Description
Atrial fibrillation (AF) is a major cardiovascular disease with a prevalence of approximately 1.2% in the general population. It accounts for 20-25% of ischemic strokes and is associated with about 30...
Eligibility Criteria
Inclusion
- Patients eligible for catheter ablation according to existing clinical guidelines
- Those without clinically significant structural heart disease (e.g., severe mitral regurgitation)
- Those without contraindications to anticoagulation therapy
Exclusion
- Atrial fibrillation associated with severe congenital heart disease or structural heart disease
- Patients with contraindications to general anesthesia or sedation for the procedure
- History of prior cardiac surgery (e.g., Maze procedure, coronary artery bypass grafting)
- History of atrial fibrillation catheter ablation within the past 12 months
- Patients with severe left ventricular dysfunction (left ventricular ejection fraction \<30%)
- Patients with active internal bleeding
- Patients with contraindications to anticoagulation therapy and antiarrhythmic drugs
- Valvular atrial fibrillation (e.g., mitral stenosis \> grade 2, mechanical valve, prior mitral valve repair)
- Patients with severe comorbid conditions
- Patients with an expected survival of less than one year
- Patients with drug or alcohol addiction
- Pregnant or breastfeeding women
- Any other conditions deemed by the investigator to make the patient unsuitable for study participation
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT06929897
Start Date
May 1 2025
End Date
October 1 2027
Last Update
April 16 2025
Active Locations (1)
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1
Ewha Womans University Mokdong Hospitoal
Seoul, South Korea