Atrial fibrillation is a common form of heart rhythm disturbance that for some patients is treated by catheter ablation (making an ablation lesion or burn inside the heart using a fine wire (catheter)). A new system for manipulating the catheters has recently been introduced into clinical practice (the Amigo Remote Catheter System (RCS)). This trial is designed to answer two primary questions: a) is the contact force (the force with which the catheter comes into contact with the heart) any different using the RCS to manual techniques,and b)are the resulting ablation lesions within the heart any different in terms of the volume and contiguity of the lesions produced. Additionally the investigators aim to determine how the two techniques compare in success (the proportion of patients whose heart rhythm disturbance is corrected by the procedure).
The trial aims to recruit 50 patients, randomised into two groups, to have ablation for atrial fibrillation performed either using the RCS, or manually. Contact force information will be collected during the procedure, but the operators will be blinded to this information. Patients will have follow-up to include post-procedural cardiac magnetic resonance imaging and ambulatory electrocardiograms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Ablation for atrial fibrillation will be performed manually
Atrial fibrillation ablation will be performed using the Amigo remote catheter system
Glenfield Hospital, Groby Road
Leicester, United Kingdom
Contact force delivered
The contact force delivered by the catheter is measured and will be compared between the two groups.
Time frame: Contact force information collected at the time of the procedures
Quantity and contiguity of ablation lesions
Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.
Time frame: 3 months post procedure
Recurrence of atrial fibrillation
Patients will be asked to attend office follow-up up to one year post procedure to assess for recurrence of atrial fibrillation.
Time frame: 1 year
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