Pulsed Field Ablation of SVC and PV in Paroxysmal Atrial Fibrillation (PASPA Study)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChanghai Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PFA - PV + SVCI
- PFA - PVI only
Treatment groups
650 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov