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OpenTrials
Completed

NCT Number: NCT02267889

Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation

This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac camera will guide the GP ablation procedure.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Brompton Hospital

London, SW3 6NP, United Kingdom

About this study

Catheter ablation procedures are nowadays routine procedures in patients with drug-refractory atrial fibrillation (AF). However, ablation success for patients even in the early stages of AF is currently only around 70% and may require multiple procedures.

The intrinsic cardiac autonomic nervous system (ANS), which forms a neural network, has been shown to be a critical element responsible for the initiation and maintenance of AF. Autonomic inputs to the heart converge at several locations; these convergence points are typically embedded in the epicardial fat pads and form ganglionated plexi (GP) that contain autonomic ganglia and nerves. In human hearts, there are at least 7 GP and the 4 major left atrial GP are located around the antrum of the pulmonary veins (PVs). High-frequency stimulation (HFS; 20 Hz, 10-150 V and pulse width 1-10 ms) can localize GP during an invasive electrophysiology (EP) study.

A novel dedicated cardiac nuclear imaging camera with solid-state detectors (D-SPECT, Spectrum Dynamics) has demonstrated significantly improved sensitivity and image resolution and can provide novel imaging information on previously 'invisible' structures like the GP. Using this 3D image information to guide GP ablation could significantly facilitate AF ablation and result in improved ablation outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Paroxysmal or early persistent atrial fibrillation with ongoing AF for less than 1 week
  • Able to give written informed consent
  • Age >18 years old and ≤ 80 years
  • Fulfil established clinical criteria for catheter ablation of atrial fibrillation
  • Normal left ventricular (LV) ejection fraction and no evidence of significant structural heart disease

Exclusion criteria

  • Reversible cause of atrial fibrillation
  • Recent cardiovascular event including transient ischaemic attack (TIA)
  • Intolerance or unwillingness to oral anticoagulation with Warfarin
  • Bleeding disorder
  • Contraindication to computed tomography (CT) scan
  • Presence of intracardiac thrombus
  • Vascular disorder preventing access to femoral veins
  • Cardiac congenital abnormality
  • Severe, life threatening non cardiac disease
  • Active malignant disease or recent (<5 years) malignant disease
  • Presence of atrial septal defect (ASD) or patent foramen ovale (PFO) closure device
  • Unable or unwilling to comply with follow-up requirements
  • Patients on amiodarone until less than 3 months prior to the screening visit
  • Left atrium size > 5.5 cm on parasternal diameter in transthoracic echocardiography (TTE)
  • Renal impairment
  • Pregnancy

Treatment and study plan

Image guided GP ablation

Procedure

3D imaging data from the D-SPECT system will be used to visualise the GP and guide the location of catheter ablation sites during the electrophysiology procedure.

Other names: D-SPECT dedicated cardiac nuclear camera

D-SPECT dedicated cardiac nuclear camera

Device

Primary outcomes

  1. Termination of atrial fibrillation during image guided ablation

    Time frame: At the time of the ablation procedure.

  2. Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.

    Time frame: 12 months post the index ablation procedure.

Secondary outcomes

  1. Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)

    Time frame: Up to 12 months from the index ablation procedure

  2. Freedom from atrial fibrillation on previously failed antiarrhythmic medication

    Time frame: 12 months from the index ablation procedure.

  3. Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure.

    Time frame: 12 months from the index ablation procedure.

    AF/flutter/tachycardia burden will be modelled as a continuous variable with the number of episodes recorded.

  4. Left atrial transport function

    Time frame: 6 months and 12 months post the index ablation procedure

    Left atrial transport function will be assessed by echo as a categorical variable with 3 categories; poor, moderately impaired and normal.

Sponsors and collaborators

Lead sponsor

Spectrum Dynamics

Industry

Registry information

Official study title

A Pilot Study on the Role pf Ganglionated Plexus Ablation for Catheter Ablation of Atrial Fibrillation.

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 20, 2014
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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