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

ConditionsParoxysmal Atrial FibrillationParoxysmal Atrial Fibrillation (PAF)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PFA - PV + SVCI

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: PVI + SVCIExperimental treatment 1 intervention
Group B: PVI onlyActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 month

Secondary outcomes

1

Atrial Fibrillation Burden

The percentage of time spent in atrial fibrillation during the 7-day Holter monitoring periods, calculated as (total AF duration / total recording duration) \* 100%.

Time frame
12 month

Other outcomes

1

Composite Rate of Major Complications

The percentage of participants experiencing any of the major complications during the 12-month follow-up period.Major complications including phrenic nerve injury/palsy, cardiac tamponade, pericardial effusion requiring intervention, symptomatic sinus node dysfunction requiring pacemaker implantation, stroke/TIA, vascular access complications, and death.

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

Source ClinicalTrials.gov

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