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)

Launched by HAUKELAND UNIVERSITY HOSPITAL · Oct 22, 2023

Keywords

ClinConnect Summary

The REPAIR PERS-AF Study is a clinical trial that aims to find the best method for treating patients with recurrent persistent atrial fibrillation (AF) who have already had previous treatments. Atrial fibrillation is a condition where the heart beats irregularly, and this study will compare two different approaches to a repeat procedure called ablation. Some patients will receive a treatment that focuses only on the pulmonary veins, while others will also have an additional step that targets the back wall of the heart. This study is for adults aged 18 to 80 who have been experiencing ongoing symptoms of AF and have had at least one prior ablation procedure.

To join the study, participants must have had recurrent AF for less than three years, have experienced episodes lasting more than a week at least once in the last six months, and have been treated with heart rhythm medications. They also need to be on blood-thinning medication for at least four weeks prior to the procedure. The trial is not yet recruiting, but if eligible, participants can expect to be randomly assigned to one of the two treatment options and will be closely monitored throughout the study. It's important to note that certain health conditions may exclude someone from participating, such as severe heart problems or complications that affect the heart's structure.

Gender

ALL

Eligibility criteria

• 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.