Status:
COMPLETED
Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation
Lead Sponsor:
Spectrum Dynamics
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19-80 years
Phase:
NA
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 ...
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 current...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02267889
Start Date
February 1 2015
End Date
December 1 2017
Last Update
February 7 2018
Active Locations (1)
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1
The Royal Brompton Hospital
London, United Kingdom, SW3 6NP