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

NCT05045131 | Completed

• 1 other identifier: PeAF-BOX study
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The safety of single procedure PVI + PWI

  Defined as the incidence of inflammation or other injury to the esophagus detected under mandated esophagoscopy on the day after PVI + PWI with radiofrequency ablation. The endoscopy is carried out, assessed and electronically stored by a board-certified gastroenterologist. Metric: n/N in %.

  Esophagoscopy is carried out at least 20 hours and less than 48 hours after the index ablation procedure

Secondary Outcomes (9)

• Feasibility of a first-procedure PVI + PWI strategy

  The data are available immediately after the end of the index PVI + PWI procedure

• Temperature in the esophagus during radiofrequency ablation

  The data are available immediately after the end of the index PVI + PWI procedure

• Durability of the PVI + PWI lesion set

  The data are available immediately after the end of the six months reassessment procedure

• AF recurrence short term

  The data are available 180 days after the index procedure

• AF burden short term

  The data are available 180 days after the index procedure

Other Outcomes (13)

• Time to PVI

  Data available immediately after index procedure

• Time to PVI + PWI

  Data available immediately after index procedure

• Total procedure time

  Data available immediately after index procedure

Study Arms (1)

PVI+PWI, 6 months reassessment procedure, 3 year continued rhythm monitoring

EXPERIMENTAL

Single arm experimental, observational study: All participants receive a single-procedure combined PVI + posterior wall isolation (PVI+PWI), loop recorder implantation, esophagoscopy, a mandated interventional reassessment /reablation procedure at six months and continuous rhythm monitoring for three years

Procedure: Left atrial combined pulmonary vein isolation and posterior wall isolation

Interventions

Left atrial combined pulmonary vein isolation and posterior wall isolation PROCEDURE

Also known as: Implantation of a subcutaneous cardiac monitor, Interventional reassessment and ablation (if needed) in the left atrium six months after the index procedure

PVI+PWI, 6 months reassessment procedure, 3 year continued rhythm monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic persistent atrial fibrillation (EHRA symptom class II or above)
• Prior failed treatment with at last one antiarrhythmic drug (Class I-IV)
• Clinical indication for ablation
• Persistent atrial fibrillation meeting both the following requirements:
• One or more episodes of atrial fibrillation lasting longer than seven days, regardless of mode of termination
• Estimated cumulated time in PeAF more than 3 months and less than 36 months

You may not qualify if:

• Contraindication for ablation
• Predominantly PAF phenotype
• Valvular Heart disease
• Previous ablation in heart
• Previous heart surgery (including valve surgery and coronary artery bypass grafting - CABG)
• Documented atrial flutter or other arrhythmia requiring ablation besides PVI
• Greatly enlarged left atrium on Trans thoracic Echocardiography (TTE ; diameter \> 52 mm in males and diameter \> 47 mm in females)
• LVEF \< 35%
• Implanted pacemaker or defibrillator
• Presence of intramural thombus, tumor or other abnormality precluding catheter introduction
• Pregnancy
• Intolerance to Amiodarone
• Unstable angina pectoris
• History of blood clotting or bleeding anomalies
• Malignant disease (non metastatic skin cancer excluded)

Sponsors & Collaborators

• René Husted Worck: lead
• Biosense Webster, Inc.: collaborator

Related Publications (2)

• Worck R, Sorensen SK, Johannessen A, Ruwald MH, Hansen ML, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation. Long-term outcomes of a repeat procedure strategy. J Interv Card Electrophysiol. 2023 Jun;66(4):971-979. doi: 10.1007/s10840-022-01402-x. Epub 2022 Nov 3.

  PMID: 36327059 DERIVED

• Worck R, Sorensen SK, Johannessen A, Ruwald M, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy. J Cardiovasc Electrophysiol. 2022 Aug;33(8):1667-1674. doi: 10.1111/jce.15556. Epub 2022 May 31.

  PMID: 35598313 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• René H Worck, MD

  Herlev-Gentofte Hospital, UCPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D. Consultant in Cardiology and Cardiac Electrophysiology

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 16, 2021
• Study Start: March 17, 2016
• Primary Completion: November 15, 2017
• Study Completion: November 14, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share