Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• Paroxysmal AF

• Age \>18 and \<80 years

• Willing and capable to provide informed consent

• Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study

Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
Contact Information
Primary
Yuri Blaauw, Dr.
y.blaauw01@umcg.nl
+31503616161
Backup
Nick van Vreeswijk, drs.
n.l.van.vreeswijk@umcg.nl
+31503616161
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2028-09
Participants
Target number of participants: 154
Treatments
Active_comparator: Radiofrequency ablation
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.
Experimental: Pulsed field ablation
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.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov