An interventional study of pulmonary vein isolation with RFA and pulmonary vein isolation with PFA in Atrial Fibrillation Recurrent, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment
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.
All participating patients are required to provide written (or equivalent) informed consent, indicated by a dated signature of the subject or legal representative. The consent process must comply with applicable national regulations and use language understandable by the patient.
The study will be conducted at 6 clinical centres/investigational sites across the Netherlands. Patients will be randomized (1:1) into a PFA or point-by-point RF ablation arm. Randomization will occur prior to the ablation procedure. A implantable cardiac monitor will be implanted in all randomised patients one month before ablation to accurately monitor any AF/atrial flutter (AFL)/ atrial tachycardia (AT) recurrence. Treatment allocation will be processed through the Dutch 'National Heart Registry' (NHR) data platform.
Patients randomized to both arms of the study will be evaluated for PV isolation at the start of the ablation procedure. If PV reconnection is identified in patients in the point-by-point RF arm, re-ablation will occur according to the study protocol. Patients in the PFA arm will have PV reconnection determined using the FARAWAVE catheter. Those with no PV reconnection (100% PV isolation/durable PVI) will be followed in an observational registry.
The PFA ablation arm involves the use of the Farastar generator system, Farawave ablation catheter, and Faradrive steering catheter for the procedure. The RF point-by-point ablation arm (control) involves RF ablation following standard practice.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 154 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who meet all of the following inclusion criteria at screening will be eligible for enrolment:
Subjects who meet ANY of the following exclusion criteria will be excluded from the study:
Any of the following within the 3 months prior to enrolment:
In this group, patients will undergo the acquisition of a 3D high-density map. If pulmonary vein (PV) reconnection is identified, radiofrequency ablation (RFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry.
Device: pulmonary vein isolation with RFA
In this group, pulmonary vein (PV) reconnection is identified by the FARAWAVE system. If reconnection is observed, pulsed field ablation (PFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry.
Device: pulmonary vein isolation with PFA
Patients randomised to RFA will undergo PVI with point-by-point RFA.
Patients 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.
Time frame: 12 months
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.
Time frame: 24 months
Repeat PVI within 12 and 24 months of randomization
Repeat PVI
Time frame: 12 and 24 months
AF burden with and without 3 months blanking period
Proportion of cumulative time in AF divided by the total time accrued over follow-up
Time frame: 12 and 24 months
Change in quality of life
As measured by EuroQol-5D-5L questionnaire
Time frame: 12 and 24 months
Change in quality of life as affected by AF
As measured by AF Effect On Quality-Of-Life (AFEQT) questionnaire
Time frame: 12 and 24 months
AF hospitalisation / urgent visit
Hospitalization/urgent visit for atrial fibrillation
Time frame: 12 and 24 months
Cost-effectiveness
Cost-effectiveness
Time frame: 12 and 24 months
Rate of ischemic stroke
Rate of ischemic stroke
Time frame: 12 and 24 months (efficacy)
Complications of ablation
Death, stroke, pericarditis, cardiac tamponade, vascular access complications etc.
Time frame: 0-30 days post ablation
Plan to share: No
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