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

NCT ID: NCT07191626

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-11-01

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.

Conditions

Paroxysmal Atrial Fibrillation; Paroxysmal Atrial Fibrillation (PAF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PVI + SVCI

Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all pulmonary veins AND the superior vena cava.

Group Type: EXPERIMENTAL

PFA - PV + SVCI

Intervention Type: PROCEDURE

Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins AND the superior vena cava.

PVI only

Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins ONLY.

Group Type: ACTIVE_COMPARATOR

PFA - PVI only

Intervention Type: PROCEDURE

Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins only. No ablation is performed in the superior vena cava.

Interventions

PFA - PV + SVCI

Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins AND the superior vena cava.

Intervention Type: PROCEDURE

PFA - PVI only

Catheter ablation procedure using a Pulsed Field Ablation system to achieve electrical isolation of all four pulmonary veins only. No ablation is performed in the superior vena cava.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhifu guo, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

songqun huang, MD

Role: CONTACT

hsq8593@163.com

+86-13585588854

zhifu guo, MD

Role: CONTACT

Facility Contacts

songqun huang, MD

Role: primary

13585588854

Other Identifiers

PASPA-2025-001

Identifier Type: -

Identifier Source: org_study_id