Status:
NOT_YET_RECRUITING
Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)
Lead Sponsor:
Changhai Hospital
Conditions:
Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation (PAF)
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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 tr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT07191626
Start Date
November 1 2025
End Date
November 1 2027
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No. 168, Changhai Road, Yangpu District, Shanghai, China.
Shanghai, Shanghai Municipality, China, 200040