Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - The REDO-PIFPAF-PFA Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation.

Eligibility criteria

Qualifiers

Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years.

Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines.

Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and/or cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus.

Age ≥ 18 years at the time of informed consent.

Disqualifiers

Previous LA surgery

> 1 prior LA ablation

LA ablation outside of the PVs in the first LA ablation

LA diameter >60 mm in the parasternal long axis

Trial design

Treatments tested in this trial

  • Pulmonary vein isolation with posterior wall ablation
  • Pulmonary vein isolation without posterior wall ablation

Treatment groups

270 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Basel, Switzerland

Lead sponsor

Swiss Heart Foundation

Collaborator

Boston Scientific Corporation

Collaborator