Atrial FibrillationNCT02267889
Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation
A study testing Image guided GP ablation and D-SPECT dedicated cardiac nuclear camera in people with Atrial Fibrillation, run by Spectrum Dynamics at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Image guided GP ablation and D-SPECT dedicated cardiac nuclear camera
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on the Role pf Ganglionated Plexus Ablation for Catheter Ablation 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Image guided GP ablation, D-SPECT dedicated cardiac nuclear camera
- Keywords
- Ganglionated plexi
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image guided GP ablationProcedure or surgery
Also called D-SPECT dedicated cardiac nuclear camera
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.
D-SPECT dedicated cardiac nuclear cameraDevice
| Study group | Role | What they receive |
|---|---|---|
| Image guided GP ablation | Experimental | Use of cardiac nuclear imaging data to guide GP ablation procedures. Receives: Procedure: Image guided GP ablation; Device: D-SPECT dedicated cardiac nuclear camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Termination of atrial fibrillation during image guided ablation
Measured: At the time of the ablation procedure.
Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.
Measured: 12 months post the index ablation procedure.
Secondary outcomes (4)
Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)
Measured: Up to 12 months from the index ablation procedure
Freedom from atrial fibrillation on previously failed antiarrhythmic medication
Measured: 12 months from the index ablation procedure.
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.
Measured: 12 months from the index ablation procedure.
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.
Measured: 6 months and 12 months post the index ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionNov 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabine Ernst, MD, Principal investigator, The Royal Brompton Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267889
- Sponsor's protocol ID
- SDRBH01
- Status last verified
- Feb 2018
- First submitted
- 14 Oct 2014
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Role pf Ganglionated Plexus Ablation for Catheter Ablation of Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT02267889
- Acronym / sponsor ID
- SDRBH01
- Conditions
- Atrial Fibrillation
- Keywords
- Ganglionated plexi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Spectrum DynamicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image guided GP ablation | Experimental | Procedure: Image guided GP ablation, Device: D-SPECT dedicated cardiac nuclear cameraUse of cardiac nuclear imaging data to guide GP ablation procedures. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image guided GP ablationAlso: D-SPECT dedicated cardiac nuclear camera3D 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. | Procedure or surgery | Image guided GP ablation |
| D-SPECT dedicated cardiac nuclear camera | Device | Image guided GP ablation |
Primary outcome
Termination of atrial fibrillation during image guided ablation
Time frame: At the time of the ablation procedure.
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.
4 secondary outcomes
Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)
Time frame: Up to 12 months from the index ablation procedure
Freedom from atrial fibrillation on previously failed antiarrhythmic medication
Time frame: 12 months from the index ablation procedure.
Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure.
Time frame: 12 months from the index ablation procedure.
Left atrial transport function
Time frame: 6 months and 12 months post the index ablation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Ernst, MD principal investigator
The Royal Brompton Hospital, London, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image guided GP ablation and D-SPECT dedicated cardiac nuclear camera in people with Atrial Fibrillation, run by Spectrum Dynamics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Termination of atrial fibrillation during image guided ablation (time frame: At the time of the ablation procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.