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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More Changhai Hospital trials in China

Other trials for the same condition