Pulmonary Vein Isolation With or Without Empiric Superior Vena Cava Isolation Using Pulsed Field Ablation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial

Pulmonary Vein Isolation With or Without Empiric Superior Vena Cava Isolation Using Pulsed Field Ablation in Patients With Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial (PFA-SVCI Trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012365

Enrollment

198

Registered

2026-07-30

Start date

2026-06-24

Completion date

Unknown

Last updated

2026-08-03

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 : • Before the procedure, all patients undergo transesophageal echocardiography or cardiac CT to rule out left atrial thrombus. All antiarrhythmic drugs except amiodarone are discont

the operator selects among the available systems. • The type of Pulsed Field Ablation system used is recorded in the case report form (CRF). • Pulmonary vein isolation (PVI) is performed using Pulsed

the primary endp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 20 to 80 years 2. Patients with paroxysmal atrial fibrillation 3. Documented Atrial fibrillation despite at least 6 weeks of continuous antiarrhythmic drug therapy 4. Able to understand the need for and the procedural process of Pulsed Field Ablation catheter ablation and to provide voluntary written informed consent 5. Able to undergo follow-up for at least 3 months after the procedure

Exclusion criteria

Exclusion criteria: 1. Left atrial size = 6.0 cm, considered unsuitable for catheter ablation 2. Prior lung surgery or structural cardiac abnormality rendering catheter ablation unsuitable 3. Previous atrial fibrillation catheter ablation 4. Persistent or permanent atrial fibrillation 5. Left atrial thrombus confirmed on transesophageal echocardiography or intracardiac echocardiography 6. Contraindication to standard therapy required before catheter ablation, such as anticoagulation 7. Belonging to a population considered vulnerable in clinical research 8. Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Incidence of atrial arrhythmia (atrial fibrillation or atrial tachycardia lasting = 30 seconds) recurring beyond the 3-month blanking period (i.e., from 3 to 12 months after the procedure), assessed by electrocardiography and 72-hour Holter monitoring.	—

Secondary

Measure	Time frame
Atrial fibrillation termination rate during the procedure;Recurrence rate of atrial fibrillation(AF) , atrial tachycardia(AT), and atrial flutter (AFL), each assessed separately, after the 3-month blanking period;Procedure-related safety (adverse events and complications);Procedure time, fluoroscopy time, and number of energy deliveries	—

Countries

Korea, Republic of

Contacts

Public Contactyujin jung

Keimyung University Dongsan Hospital

jinew326@naver.com+82-53-258-4628

Outcome results