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Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

Study acronym: GANGLIA-AF
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Results first posted: Sep 23, 2024 Primary completion date: Jan 2021 to Oct 23, 2023 · Start date: Dec 2013 to Dec 1, 2017 · Primary endpoint revised · 4 morev5 Show 7 more changesShow less
    • Primary completion date: Jan 2021 to Oct 23, 2023
    • Start date: Dec 2013 to Dec 1, 2017
    • Primary endpoint revised
    • Trial status: Completed to Active, Not Recruiting
    • Enrollment target: estimated 180 to confirmed 116
    • Completion date: Jan 2021 to Oct 23, 2024
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Completed Primary and study completion dates changed from estimate of Sep 2020 to Jan 2021 · Site details revised at 3 of 3 sitesv4 Show 2 more changesShow less
    • Primary and study completion dates changed from estimate of Sep 2020 to Jan 2021
    • Site details revised at 3 of 3 sites
  4. Primary endpoints: 4 to 1 Study sites: 2 to 3 · Interventions: Ganglionic plexi ablation (Procedure), Pulmonary vein isolation (Procedure) to Ganglionated plexus ablation (Procedure), Pulmonary vein isolation (Procedure) · Eligibility criteria shortened, about 16 words · 3 morev3 Show 6 more changesShow less
    • Study sites: 2 to 3
    • Interventions: Ganglionic plexi ablation (Procedure), Pulmonary vein isolation (Procedure) to Ganglionated plexus ablation (Procedure), Pulmonary vein isolation (Procedure)
    • Eligibility criteria shortened, about 16 words
    • Secondary endpoint revised
    • Study description shortened, about 293 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Oct 2016 to Sep 2020 Study sites: 3 to 2 · Completion date: Nov 2016 to Sep 2020v2 Show 2 more changesShow less
    • Study sites: 3 to 2
    • Completion date: Nov 2016 to Sep 2020
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes. Abnormal electrical activity from the pulmonary veins are thought to be the most common cause of this condition. Current ablative strategy in drug refractory AF is pulmonary vein isolation (PVI), where the pulmonary veins are electrically isolated from the body of the left atrium. However, success rate of this procedure remain \~50-70% for a single procedure despite advances in mapping and ablation techniques. Ganglionated plexuses (GP) are dense clusters of nerves in the atria that are implicated in AF. Endocardial high frequency stimulation (HFS) delivered within the local atrial refractory period can trigger ectopy and AF from specific GP sites (ET-GP). The aim of this study was to understand the role of ET-GP ablation in the treatment of AF by comparing two different strategies: 1. Pulmonary vein isolation alone 2. GP ablation alone
Trial Details
NCT Number NCT02487654
Lead Sponsor Imperial College London
Conditions Paroxysmal Atrial Fibrillation
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov