Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA). However, in cases requiring a second PVI for recurrent AF, radiofrequency ablation (RFA) is utilized in nearly 95% of instances post-acquiring a 3D high-density map from the left atrium (LA). Up to 85% of patients experiencing recurrent AF after the initial PVI exhibit pulmonary vein (PV) reconnections, often identified as the cause of AF.
PFA has demonstrated its safety and efficiency compared to RFA as a swift technique for performing ablation. Yet, whether PFA or RFA stands out as superior or safer when applied for a second PVI remains unclear, as no randomized controlled trial has investigated this comparison. The proposed REPEAT-AF trial aims to randomize 154 AF patients experiencing recurrent AF after the initial PVI, assigning them in a 1:1 ratio to either RFA or PFA. Each patient will receive an implantable cardiac monitor to precisely detect any AF recurrences.
Patient had 1 previous PVI with either cryoballoon, RF ablation or PFA
Index PVI occurred within <5 years prior to enrolment
Documented AF recurrence >30 seconds
Symptomatic AF
Persistent AF (by diagnosis of duration >7 days)
Concomitant/ prior diagnosis for atrial tachycardia (AT) and/or atrial flutter (AFl). Note typical cavotricuspid isthmus dependent flutter is not an exclusion criterium.
Underwent additional ablations outside the pulmonary veins during index AF ablation
AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
Parallel
pulmonary vein isolation with RFA
DevicePatients randomised to RFA will undergo PVI with point-by-point RFA.
pulmonary vein isolation with PFA
DevicePatients randomised to PFA will undergo PVI with PFA.
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.
12-month incidence of AF/AFl/AT recurrence.
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.
24-month incidence of AF/AFl/AT recurrence.
Repeat PVI within 12 and 24 months of randomization
Repeat PVI
AF burden with and without 3 months blanking period
Proportion of cumulative time in AF divided by the total time accrued over follow-up
Change in quality of life
As measured by EuroQol-5D-5L questionnaire
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
Boston Scientific Corporation
Collaborator
