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CFAE/Spatiotemporal Dispersion Guided Ablation Versus PVI Guided Ablation in Persistent AF

NCT02696265 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-07-13

No results posted yet for this study

Summary

Objective: The purpose of this study is to compare the efficacy and safety of ablation of Atrial Fibrillation (AF) drivers marked by spatiotemporal dispersions and Complex Fractionated Atrial Electrocardiograms (CFAEs) to Pulmonary Vein Isolation (PVI) based ablation in patients with persistent AF.

Hypothesis: CFAE/spatiotemporal dispersion guided ablation will increase AF free survival compared to a PVI guided ablation.

Patient population: Patients with persistent AF will be randomized based on a 2:1 ratio into one of two study arms:

* CFAE/spatiotemporal dispersion guided ablation: CFAE mapping and ablation during AF aimed at restoring sinus rhythm during ablation.
* PVI guided ablation: wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals

Conditions

  • Chronic Atrial Fibrillation

Interventions

PROCEDURE

CFAE guided ablation

CFAE/spatiotemporal dispersions mapping and ablation during AF aimed at restoring sinus rhythm during ablation. Pulmonal vein isolation will be checked before and after ablation using a mapping catheter.

PROCEDURE

PVI guided ablation

Wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Johnson & Johnson

    collaborator INDUSTRY

  • Diagram B.V.

    lead OTHER

Principal Investigators

  • Jaap-Jan J. Smit, MD, PhD · Isala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-12
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • France
  • Japan
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

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 NCT02696265 on ClinicalTrials.gov