Status:

WITHDRAWN

Clinical Outcomes of Persistent Atrial Fibrillation Ablation Using Ablation Index-guided Radiofrequency Catheter Ablation in Patients With Continuous Monitoring

Lead Sponsor:

St. Louis University

Conditions:

Persistent Atrial Fibrillation

Eligibility:

All Genders

18+ years

Brief Summary

Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart. Tablets to try to normalize the heart rhythm rarely work well. As a result, doctors have devised a treatment call...

Detailed Description

Single-center, prospective cohort study including patients with persistent AF (PeAF). Primary Hypothesis: Single AF ablation procedure that includes PVI achieved with point-by-point Wide Area Circum...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Aged over 18 years
  • Persistent AF defined according to the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, as AF episode that lasts longer than 7 days. (Calkins et al., 2017)
  • Symptomatic despite drug treatment.
  • Due to undergo AF ablation.
  • Exclusion criteria:
  • Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA) or non-VKA (NOAC) agent
  • Previous catheter or surgical ablation procedure for AF
  • Unwillingness or inability to complete the required follow-up arrangements
  • Current pattern of paroxysmal AF
  • Long standing persistent AF (continuous AF longer than 12 months before ablation)
  • Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
  • Known infiltrative cardiomyopathy
  • Known severe left ventricular systolic function (ejection fraction \<35%)
  • Pregnancy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 30 2025

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT05406310

    Start Date

    May 1 2024

    End Date

    June 30 2025

    Last Update

    July 15 2024

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