Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)

Not Applicable

Not yet recruiting

• Conditions: Paroxysmal Atrial Fibrillation; Paroxysmal Atrial Fibrillation (PAF)

• Registration Number: NCT07191626
• Lead Sponsor: Changhai Hospital

Brief Summary

The PASPA study is a multicenter, randomized trial comparing Pulmonary Vein Isolation (PVI) alone versus PVI plus Superior Vena Cava Isolation (SVCI) using Pulsed Field Ablation (PFA) in patients with paroxysmal atrial fibrillation (PAF).

650 participants will be followed for 12 months. The main goal is to see if adding SVCI reduces arrhythmia recurrence without increasing complications such as phrenic nerve injury or sinus node dysfunction.

Detailed Description

The PASPA study addresses the limitations of traditional pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF), where recurrence rates remain significant due to non-pulmonary vein triggers such as the superior vena cava (SVC). Traditional ablation near the SVC carries risks of phrenic nerve and sinus node injury, and acute isolation success rates are only 75%-85%. Pulsed Field Ablation (PFA) selectively ablates cardiomyocytes through irreversible electroporation while sparing adjacent nerves and vessels, allowing safer SVC isolation. This prospective, multicenter, randomized controlled trial will enroll 650 patients with documented PAF, randomly assigned to PVI alone or PVI plus SVC isolation (SVCI) using PFA. Participants will be followed for 12 months with 7-day Holter monitoring at 3, 6, and 12 months. The primary endpoint is freedom from atrial fibrillation, atrial flutter, or atrial tachycardia episodes ≥30 seconds at 12 months. Secondary endpoints include atrial fibrillation burden and procedure-related complications such as phrenic nerve injury, cardiac tamponade, and sinus node dysfunction. Preliminary animal and pilot human studies indicate that PFA achieves 100% acute SVC isolation with minimal complications. The study aims to determine whether adding SVCI to PVI improves efficacy in PAF without increasing procedural risks, providing evidence to guide standardized ablation strategies.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Study Start: 2025-11-01
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

1. Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor
2. Age between 18 and 80 years
3. Willing and able to provide written informed consent

Exclusion Criteria

1. Intracardiac thrombus (left atrium or left atrial appendage)
2. Left atrial anterior-posterior diameter > 60 mm
3. Absolute contraindication to anticoagulation therapy
4. Stroke or myocardial infarction within 1 month prior to enrollment
5. Uncontrolled hyperthyroidism
6. Pregnancy or planning pregnancy
7. Life expectancy less than 1 year
8. Previous atrial fibrillation ablation procedure
9. Known or suspected AF triggers primarily originating from the SVC (based on pre-procedure mapping, if available)
10. Inability or unwillingness to participate in the study or comply with follow-up requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmia recurrence at 12 Months	12 month	Proportion of participants without recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds, as assessed by 7-day continuous ambulatory ECG monitoring, during the 12-month follow-up period after ablation.

Secondary Outcome Measures

Name	Time	Method
Atrial Fibrillation Burden	12 month	The percentage of time spent in atrial fibrillation during the 7-day Holter monitoring periods, calculated as (total AF duration / total recording duration) \* 100%.

Trial Locations

Locations (1)

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No. 168, Changhai Road, Yangpu District, Shanghai, China.; 🇨🇳 Shanghai, Shanghai Municipality, China