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The Effect of Additional Superior Vena Cava Isolation on Clinical Outcomes in Patients with Atrial Fibrillation Undergoing Pulmonary Vein Isolation Using Pulsed Field Ablation: A Multicenter Prospective Randomized Controlled Trial

The Effect of Additional Superior Vena Cava Isolation on Clinical Outcomes in Patients with Atrial Fibrillation Undergoing Pulmonary Vein Isolation Using Pulsed Field Ablation: A Multicenter Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011259
Enrollment
124
Registered
2025-12-05
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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 : Pulmonary vein isolation (PVI) using pulsed field ablation (PFA) will be performed in all study participants. In addition, the intervention group will undergo superior vena cava is

Sponsors

Chung-Ang University Gwangmyeong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing pulsed field ablation (PFA) for atrial fibrillation (AF) for the first time. 2. Patients with documented failure of at least one antiarrhythmic drug therapy or with a medical contraindication to the use of antiarrhythmic drugs. 3. Patients who are able to voluntarily provide written informed consent after receiving a full explanation of the study. 4. Patients aged 18 years or older. 5. Patients with sufficient mental and linguistic capacity to understand the purpose of the clinical trial and to comply appropriately with the study procedures.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of prior catheter ablation for atrial fibrillation. 2. Patients with comorbid conditions expected to limit life expectancy to less than one year. 3. Patients who have participated in, or are currently participating in, a clinical trial involving drugs, medical devices, or biologics within the past 2 months. 4. Pregnant or breastfeeding women, or women of childbearing potential who are not using adequate contraception. 5. Patients with a history of hemorrhagic disorders or cerebrovascular accidents within the past 3 months, or with ongoing such conditions. 6. Patients with active systemic infections or inflammatory diseases. 7. Patients who have undergone cardiac surgery or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Freedom from atrial tachyarrhythmia recurrence;Incidence of procedure-related adverse events or complications

Secondary

MeasureTime frame
Total procedure duration

Countries

Korea, Republic of

Contacts

Public ContactHONG EUY LIM

Chung-Ang University Gwangmyeong Hospital

hongeuy1046@gmail.com+82-2-2222-1252

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026