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Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

NCT02487654 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-09-23

Study results available
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Summary

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

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

Pulmonary vein isolation

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

PROCEDURE

Ganglionated plexus ablation

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Prapa Kanagaratnam, PhD · Imperial College NHS Healthcare Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2023-10-23
Completion
2024-10-23

Countries

  • United Kingdom

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 NCT02487654 on ClinicalTrials.gov