Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation Recurrent
• Interventions: Device: pulmonary vein isolation with RFA; Device: pulmonary vein isolation with PFA

• Registration Number: NCT06199180
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-10
• Study Start: 2024-09-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablation	pulmonary vein isolation with RFA	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.
Pulsed field ablation	pulmonary vein isolation with PFA	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.

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.	12 months	12-month incidence of AF/AFl/AT recurrence.

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.	24 months	24-month incidence of AF/AFl/AT recurrence.
Repeat PVI within 12 and 24 months of randomization	12 and 24 months	Repeat PVI
AF burden with and without 3 months blanking period	12 and 24 months	Proportion of cumulative time in AF divided by the total time accrued over follow-up
Change in quality of life	12 and 24 months	As measured by EuroQol-5D-5L questionnaire
Change in quality of life as affected by AF	12 and 24 months	As measured by AF Effect On Quality-Of-Life (AFEQT) questionnaire
AF hospitalisation / urgent visit	12 and 24 months	Hospitalization/urgent visit for atrial fibrillation
Cost-effectiveness	12 and 24 months	Cost-effectiveness
Rate of ischemic stroke	12 and 24 months (efficacy)	Rate of ischemic stroke
Complications of ablation	0-30 days post ablation	Death, stroke, pericarditis, cardiac tamponade, vascular access complications etc.

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands