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

NCT ID: NCT05045131

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-17
• Study Completion Date: 2020-11-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Left atrial combined pulmonary vein isolation and posterior wall isolation

Intervention Type: PROCEDURE

Interventions

Left atrial combined pulmonary vein isolation and posterior wall isolation

Intervention Type: PROCEDURE

Other Intervention Names

Implantation of a subcutaneous cardiac monitor; Interventional reassessment and ablation (if needed) in the left atrium six months after the index procedure

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Myocardial infarction within 3 months of inclusion
• History of blood clotting or bleeding anomalies
• Malignant disease (non metastatic skin cancer excluded)
• Severe obesity (Mody mass index > 35 kg/m^2)
• Active systemic infection
• Renal insufficiency (serum creatinine > 150 mmoles/liter)
• Psychiatric illness
• Substance abuse
• Participation in other clinical trials

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

René Husted Worck

OTHER

Sponsor Role: lead

Responsible Party

René Husted Worck

M.D. Consultant in Cardiology and Cardiac Electrophysiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

René H Worck, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev-Gentofte Hospital, UCPH

References

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.

Reference Type: DERIVED

PMID: 36327059 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35598313 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PeAF-BOX study

Identifier Type: -

Identifier Source: org_study_id