Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267889
• Other study ID #: SDRBH01
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: February 6, 2018
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Spectrum Dynamics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Image guided GP ablation
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.

Device:
• D-SPECT dedicated cardiac nuclear camera

Locations

Country	Name	City	State
United Kingdom	The Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Dynamics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Termination of atrial fibrillation during image guided ablation		At the time of the ablation procedure.
Primary	Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.		12 months post the index ablation procedure.
Secondary	Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)		Up to 12 months from the index ablation procedure
Secondary	Freedom from atrial fibrillation on previously failed antiarrhythmic medication		12 months from the index ablation procedure.
Secondary	Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure.	AF/flutter/tachycardia burden will be modelled as a continuous variable with the number of episodes recorded.	12 months from the index ablation procedure.
Secondary	Left atrial transport function	Left atrial transport function will be assessed by echo as a categorical variable with 3 categories; poor, moderately impaired and normal.	6 months and 12 months post the index ablation procedure