NCT05045131: PeAF-BOX

PeAF-BOX: Feasibility, Safety and Efficacy of PVI + Box Ablation in Persistent Atrial Fibrillation

Completed NA Last updated 16 September 2021

What this trial tests

NA trial testing Left atrial combined pulmonary vein isolation and posterior wall isolation in Atrial Fibrillation in 24 participants. Completed in 14 November 2020.

Timeline

17 March 2016

Primary endpoint
15 November 2017

14 November 2020

Quick facts

Lead sponsor	René Husted Worck
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	17 March 2016
Primary completion	15 November 2017
Estimated completion	14 November 2020

Drugs / interventions tested

• Left atrial combined pulmonary vein isolation and posterior wall isolation

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

René Husted Worck

Who can join

Adults 18 to 75, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy.
   Worck R, Sørensen SK, Johannessen A, Ruwald M, et al · · 2022 · cited 22× · PMID 35598313 · DOI 10.1111/jce.15556
2. Posterior wall isolation in persistent atrial fibrillation. Long-term outcomes of a repeat procedure strategy.
   Worck R, Sørensen SK, Johannessen A, Ruwald MH, et al · · 2023 · cited 6× · PMID 36327059 · DOI 10.1007/s10840-022-01402-x