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Effectiveness and Safety of Pulsed Field Ablation (PFA)-based Pulmonary Vein Isolation versus Phenotype-based Tailored Adjunctive Ablation in Patients with Persistent Atrial Fibrillation: A Randomized Controlled Trial

Effectiveness and Safety of Pulsed Field Ablation (PFA)-based Pulmonary Vein Isolation versus Phenotype-based Tailored Adjunctive Ablation in Patients with Persistent Atrial Fibrillation: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012416
Enrollment
204
Registered
2026-08-07
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : - Pre-procedural Evaluation and Medication Adjustment: All patients will undergo transesophageal echocardiography or cardiac CT prior to the procedure to rule out left atrial throm

Sponsors

Keimyung University Dongsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Patients with persistent atrial fibrillation 3. Patients with atrial fibrillation persisting despite continuous antiarrhythmic drug therapy for =6 weeks 4. Patients who understand the explanation regarding the need for and procedural process of catheter ablation using pulsed field ablation, and who voluntarily provide written informed consent 5. Patients able to undergo follow-up for at least 12 months after the procedure

Exclusion criteria

Exclusion criteria: 1. Patients with a left atrial diameter =6.0 cm, rendering them unsuitable for pulsed field ablation 2. Patients with a history of prior lung surgery or structural cardiac abnormalities that render them unsuitable for pulsed field ablation 3. Patients with contraindications to standard therapy—such as anticoagulation therapy—that must be maintained prior to pulsed field ablation 4. Patients belonging to vulnerable populations in clinical research 5. Patients who have previously undergone catheter ablation or pulsed field ablation for atrial fibrillation 6. Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Incidence of atrial arrhythmia (atrial fibrillation or atrial tachycardia lasting =30 seconds) occurring from 3 months to 1 year after the procedure (assessed by electrocardiogram and 72-hour Holter monitoring)

Secondary

MeasureTime frame
Rate of atrial fibrillation termination during the procedure;Recurrence rate of Atrial fibrillation/Atrial Tachycardia/Atrial flutter individually after the 3-month blanking period;Procedure-related safety (presence of adverse events or complications);Procedure time, fluoroscopy time, and number of energy applications

Countries

Korea, Republic of

Contacts

Public ContactHyungseop Park

Keimyung University Dongsan Hospital

drparkgyver@gmail.com+82-53-258-4628

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Aug 25, 2026