Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
St. Olavs Hospital
University Hospital of North Norway
Conditions:
Atrial Fibrillation, Persistent
Atrial Fibrillation Recurrent
Eligibility:
All Genders
18-80 years
Phase:
NA
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) alo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06098989
Start Date
November 15 2023
End Date
November 15 2026
Last Update
October 25 2023
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