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

NCT07191626 | Not Yet Recruiting DMC

• 1 other identifier: PASPA-2025-001
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation; Paroxysmal Atrial Fibrillation (PAF)

Keywords

Paroxysmal, Catheter Ablation; Catheter Ablation; Pulsed Field Ablation; Pulmonary Vein Isolation; Superior Vena Cava Isolation

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrhythmia recurrence at 12 Months

  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.

  12 month

Secondary Outcomes (1)

• Atrial Fibrillation Burden

  12 month

Other Outcomes (1)

• Composite Rate of Major Complications

  12 months

Study Arms (2)

PVI + SVCI

EXPERIMENTAL

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

Procedure: PFA - PV + SVCI

PVI only

ACTIVE COMPARATOR

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

Procedure: PFA - PVI only

Interventions

PFA - PV + SVCI 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 + SVCI

PFA - PVI only 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.

PVI only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• zhifu guo, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

songqun huang, MD

CONTACT

+86-13585588854; hsq8593@163.com

zhifu guo, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a parallel assignment design. Eligible participants are randomly assigned in a 1:1 ratio to one of two study arms: (1) pulsed field ablation guided pulmonary vein isolation (PVI alone), or (2) pulsed field ablation guided pulmonary vein isolation plus superior vena cava isolation (PVI + SVC). Each participant receives only the intervention of the assigned arm. Randomization is stratified by study center to ensure balanced allocation across all 20 participating centers.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 25, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available starting 12 months after publication of the primary results, for a duration of 12 months.
• Access Criteria: Access granted only to qualified researchers upon reasonable request. Only de-identified participant-level data will be shared. Requests are subject to sponsor approval.

Locations

CN (1)