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)

NCT06098989 | Not Yet Recruiting DMC

• 1 other identifier: 626136
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation, Persistent; Atrial Fibrillation Recurrent

Keywords

Atrial fibrillation; Radiofrequency ablation; Posterior wall isolation; Pulmonary vein isolation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Complications and adverse events

  12 months

• Procedure time

  During the procedure

• Ablation time

  During the procedure

• Fluoroscopy time

  During the procedure

• Quality of life assessment 1

  12 months

Study Arms (3)

Normal voltage in LA posterior wall - PVI alone

ACTIVE COMPARATOR

Patients with normal LA posterior wall will be assigned directly to arm 1, receiving PVI alone.

Procedure: Radio frequency ablation

Low voltage in LA posterior wall - PVI alone

ACTIVE COMPARATOR

Patients with low voltage/scar on the LA posterior wall will be randomized to arm 2, receiving PVI alone.

Procedure: Radio frequency ablation

Low voltage in LA posterior wall - PVI + PWI

ACTIVE COMPARATOR

Patients with low voltage/scar on the LA posterior wall will be randomized to arm 3, receiving PVI + PWI.

Procedure: Radio frequency ablation

Interventions

Radio frequency ablation PROCEDURE

Radio frequency ablation

Low voltage in LA posterior wall - PVI + PWI; Low voltage in LA posterior wall - PVI alone; Normal voltage in LA posterior wall - PVI alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jian Chen, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian Wollner, MD

CONTACT

92229412; wollnerkristian@gmail.com

Jian Chen, MD, PhD

CONTACT

91198931; jian.chen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, open-labeled, partly randomized study.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 25, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: October 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share