A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation: Pulmonary Vein Isolation vs. Adjunct Posterior Wall Isolation (REPAIR PERS-AF Study) (REPAIR PERS-AF)

This study aims to investigate the best strategy for repeat ablation of recurrent persistent atrial fibrillation (AF) after previous persistent AF ablation involving pulmonary vein isolation (PVI) along. Patients with low voltage areas on the posterer wall will be randomized to PVI alone or the posterer wall isoaltion (PWI) in addition to PVI.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation Recurrent
• Intervention / Treatment: Procedure: Radio frequency ablation

Detailed Description

This study aims to find a optmal strategy for repeat ablation for recurrent persistent AF after previous persistent AF ablation involving only PVI. PVI is an evident and well documented target for AF ablation. Many other ablation approaches beyond PVI have been reported. PWI is one of the frequently applied methods. However, this appoach has not been studied in randomized clinical trials for recurrent persistent AF after index procedure, thus evidence is demanded for guidance of clinical practice for AF ablation.

The purpose of this study is to clarify this matter by comparing PVI alone strategy with the approach of PVI plus PWI in patients with recurrent persistent AF after index ablation procedure. Since previous clinical studies have shown better outcomes of ablation among patients with normal left atrium (LA) than those with sick LA, ablation strategies in this study will be selected based on voltage mapping of the LA, avoiding unnecessary ablation applications.

The investigators hypothesize that PVI is good enough for patients with normal LA (normal voltage ≥0.5 mV); Among patients with low voltage/scar (voltage < 0.5 mV), PVI plus PWI is superior to PVI alone.

This study is a prospective, multi-center, open-labeled, partly randomized study. After enrollment, patients will receive a voltage mapping of the LA which is routine for all AF ablation procedures. Based on the mapping results, patients will be stratified into two strata, normal voltage (≥ 0.5 mV) and low voltage (< 0.5 mV) in the LA posterior wall. Patients with normal voltage in the LA posterior wall will be directly assigned to arm 1 receiving PVI alone treatment (avoid unnecessary ablation of healthy myocardium). Patients with low voltage will be 1:1 randomized in arms 2 and 3 receiving either PVI alone or PVI + PWI treatment.

1. Arm 1: Normal voltage in LA posterior wall - PVI alone
2. Arm 2: Low voltage in LA posterior wall - PVI alone
3. Arm 3: Low voltage in LA posterior wall - PVI + PWI

Three Norwegian University Hospitals, including Haukeland University Hospital, Bergen, St. Olavs Hospital, Trondheim, and University Hospital of North Norway, Tromsø, will participate in this study. The study is expected to last 3 years, 24 months for enrollment and each patient will be followed for a period of 12 months.

In order to minimize bias, subjects will be randomized next to the LA mapping. Patients will be analyzed according to their initial randomization, that is intention-to-treat, even if they never start the treatment, or discontinue, or cross over the group.

Patents will be followed in out-patient clinic at 3, 6 and 12 months after the treatment.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristian Wollner, MD; Phone Number: +47 92229412; Email: wollnerkristian@gmail.com
• Study Contact Backup: Name: Jian Chen, MD, PhD; Phone Number: +47 91198931; Email: jian.chen@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Symptomatic patients with persistent AF and indication for repeat ablation
• procedure.
• Patients with recurrent persistent AF (with a duration <3 year, at least one episode longer than 7 days during the last 6 months and have been electrically cardioverted at least once during the last 12 months) after previous catheter ablation.
• Patients with up to two previous catheter ablations for AF are included if the procedures only involved PVI. Previous PVI procedure(s) with both cryoablation and radiofrequency ablation are accepted.
• Patients have taken at least one antiarrhythmic drug.
• Patients are willing to participate in the study and sign the patient information form.
• Age: 18-80 years old.
• Patients must be on continuous anticoagulation with warfarin (INR 2-3) or direct oral anticoagulant for >4 weeks prior to the ablation.

Exclusion Criteria:

• Patients with >2 ablation procedures in the LA for AF or atrial flutter
• Previous ablation procedures for AF involving ablation strategies beyond PVI
• Duration of persistent AF >3 years
• Presence of atrial flutter or atrial tachycardia
• Presence of an intracavitary thrombus
• Uncontrolled heart failure
• Severe valvular disease
• LA diameter > 60 mm
• Structural heart disease involving more than moderate valvular stenosis and/or
• Insufficiencies
• Rheumatic heart disease
• Cardiac surgery for valvopathy or for congenital heart disease
• Patients with contraindications to systemic anticoagulation
• Severe renal dysfunction
• Patients who are or may potentially be pregnant.
• Patient not able to be followed up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal voltage in LA posterior wall - PVI alone; Patients with normal LA posterior wall will be assigned directly to arm 1, receiving PVI alone.	Procedure: Radio frequency ablation; Radio frequency ablation
Active Comparator: Low voltage in LA posterior wall - PVI alone; Patients with low voltage/scar on the LA posterior wall will be randomized to arm 2, receiving PVI alone.	Procedure: Radio frequency ablation; Radio frequency ablation
Active Comparator: Low voltage in LA posterior wall - PVI + PWI; Patients with low voltage/scar on the LA posterior wall will be randomized to arm 3, receiving PVI + PWI.	Procedure: Radio frequency ablation; Radio frequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial tachyarrhythmias with duration >30 seconds	Alle episodes of atrial tachyarrhythmia (atrial fibrillation, atrial flutter of atrial tachycardia) with duration >30 seconds recorded 3-months after the ablation procedure will be regarded as recurrence. Blanking period is defined as 3 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications and adverse events	All periprocedural complications and adverse events during follow-up	12 months
Procedure time	Procedure time will be recorded and reported.	During the procedure
Ablation time	Ablation time will be recorded and reported.	During the procedure
Fluoroscopy time	Fluoroscopy time will be recorded and reported.	During the procedure
Quality of life assessment 1	AF Effect On Quality-Of-Life Questionnaire (AFEQT, scores range 0-100, higher scores mean a worse outcome)	12 months
Quality of life assessment 2	Assessed by Short Form (36) Heath Survey (SF-36, scores range 0-100, higher scores mean a better outcome)	12 months
Frequency of atypical atrial flutter	Incidence of atypical atrial flutter will be reported.	12 months

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University Hospital of North Norway; St. Olavs Hospital
• Investigators: Principal Investigator: Jian Chen, MD, PhD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 22, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Radiofrequency ablation; Pulmonary vein isolation; Posterior wall isolation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 626136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No