PeAF-BOX: Feasibility, Safety and Efficacy of PVI + Box Ablation in Persistent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Title: PeAF-Box. Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall
      (PWI) added to Pulmonary Vein Isolation (PVI) as First-Line Strategy in Treatment of
      Persistent Atrial Fibrillation (PeAF)

      Design: A prospective, observational, single center, unblinded, clinical study with 3 years
      of follow-up and two interventional procedures: An index ablation procedure and a
      reassessment/ reablation procedure after 6 months.

      Background: In patients with PeAF the effect of first-line ablation with pulmonary vein
      isolation (PVI) is smaller than in patients with paroxysmal atrial fibrillation (PAF), where
      PVI alone is effective in reducing symptoms and increasing quality of life. Adding PWI to PVI
      is increasingly used despite concerns about safety and efficacy.

      Objectives: (1) To use PVI + PWI as first-line ablation-strategy in participants with PeAF
      and to assess the feasibility of obtaining that goal. (2) To assess the safety of applying
      this lesion set - in terms of heat-induced injury to the esophagus - using esophagoscopy. 3)
      To asses arrhythmia burden using continuous monitoring for 3 years after ablation. (4) To
      assess the durability of the PVI + PWI lesion set by a relook/ reablation procedure after 6
      months. (5) To follow the effect of PVI + PWI on participants' quality of life over three
      years.

      Study site: Dept of Cardiology - Electrophysiology Laboratory, Gentofte Hospital, University
      of Copenhagen.

      Study population: 24 patients referred for ablation of PeAF are asked for informed consent
      for these elements that surpass standard treatment in PeAF: (1) Taking amiodarone for 3 weeks
      prior to the index procedure to 3 weeks after the procedure, (2) Additional ablation with PWI
      compared to standard first-line therapy with PVI only. (3) Implantation of an implantable
      cardiac monitor (ICM), (4) Post-procedure esophagoscopy, (5) Regular clinic visits for 3
      years post procedure, (6) Undergoing an interventional relook/ reablation procedure 6 months
      after the index procedure.

      Anticoagulation drugs during the procedure and follow up: To prevent thromboses participants
      are prescribed periprocedural oral anticoagulant treatment to be continued for shorter or
      longer/lifelong periods according to the participants' risk of thrombosis (the CHA2DS2-VASC
      score).

      Anti-arrhythmic drugs (AADs): Except from periprocedural amiodarone treatment, no AADs are
      allowed during the follow-up apart from occurrence of otherwise untreatable arrhythmias.
    


Intervention name(s): Left atrial combined pulmonary vein isolation and posterior wall isolation
Intervention type(s): Procedure
Other intervention name(s): Implantation of a subcutaneous cardiac monitor; Interventional reassessment and ablation (if needed) in the left atrium six months after the index procedure
Intervention model: Single Group Assignment
Intervention model description: The PeAF - Box study is observational and investigates single procedure PVI+PWI. Adding PWI to PVI substantially increases the amount of ablation close to the esophagus raising concerns of the risk of esophageal thermal injury. Accordingly, the study includes a formal analysis of the safety of PVI+PWI in terms of risk of esophageal thermal injury. The study includes 24 participants based on power calculations showing that at least 23 participants were required to illustrate a non-inferior risk of inducing esophageal thermal injury by PVI+PWI compared to relevant recently published data.
Masking: None (Open Label)
Primary purpose: Treatment