Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Image guided GP ablation
D-SPECT dedicated cardiac nuclear camera
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Ganglionated plexi
Eligibility Criteria
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
Sites / Locations
- The Royal Brompton Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Image guided GP ablation
Arm Description
Use of cardiac nuclear imaging data to guide GP ablation procedures.
Outcomes
Primary Outcome Measures
Termination of atrial fibrillation during image guided ablation
Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.
Secondary Outcome Measures
Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)
Freedom from atrial fibrillation on previously failed antiarrhythmic medication
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02267889
Brief Title
Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation
Official Title
A Pilot Study on the Role pf Ganglionated Plexus Ablation for Catheter Ablation of Atrial Fibrillation.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Dynamics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Ganglionated plexi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Image guided GP ablation
Arm Type
Experimental
Arm Description
Use of cardiac nuclear imaging data to guide GP ablation procedures.
Intervention Type
Procedure
Intervention Name(s)
Image guided GP ablation
Other Intervention Name(s)
D-SPECT dedicated cardiac nuclear camera
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
D-SPECT dedicated cardiac nuclear camera
Primary Outcome Measure Information:
Title
Termination of atrial fibrillation during image guided ablation
Time Frame
At the time of the ablation procedure.
Title
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 Outcome Measure Information:
Title
Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)
Time Frame
Up to 12 months from the index ablation procedure
Title
Freedom from atrial fibrillation on previously failed antiarrhythmic medication
Time Frame
12 months from the index ablation procedure.
Title
Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure.
Description
AF/flutter/tachycardia burden will be modelled as a continuous variable with the number of episodes recorded.
Time Frame
12 months from the index ablation procedure.
Title
Left atrial transport function
Description
Left atrial transport function will be assessed by echo as a categorical variable with 3 categories; poor, moderately impaired and normal.
Time Frame
6 months and 12 months post the index ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Ernst, MD
Organizational Affiliation
The Royal Brompton Hospital, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation
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