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)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHaukeland University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radio frequency ablation

    Procedure/Surgery

    Radio frequency ablation

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Normal voltage in LA posterior wall - PVI aloneActive comparator 1 intervention
Group B: Low voltage in LA posterior wall - PVI aloneActive comparator 1 intervention
Group C: Low voltage in LA posterior wall - PVI + PWIActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Complications and adverse events

All periprocedural complications and adverse events during follow-up

Time frame
12 months
2

Procedure time

Procedure time will be recorded and reported.

Time frame
During the procedure
3

Ablation time

Ablation time will be recorded and reported.

Time frame
During the procedure
4

Fluoroscopy time

Fluoroscopy time will be recorded and reported.

Time frame
During the procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

St. Olavs Hospital

Collaborator

University Hospital of North Norway

Collaborator

This trial is not recruiting at the moment. You can still explore other options: