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

NCT06199180 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-12-10

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation Recurrent

Interventions

DEVICE

pulmonary vein isolation with RFA

Patients randomised to RFA will undergo PVI with point-by-point RFA.

DEVICE

pulmonary vein isolation with PFA

Patients randomised to PFA will undergo PVI with PFA.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Yuri Blaauw, Dr. · UMCG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06199180 on ClinicalTrials.gov