Manual vs Amigo SmartTouch Atrial Fibrillation Study
This trial is active, not recruiting.
|Treatments||catheter ablation for atrial fibrillation, manual, ablation using amigo remote catheter system|
|Sponsor||University of Leicester|
|Start date||April 2012|
|End date||December 2015|
|Trial size||50 participants|
|Trial identifier||NCT01583855, UNOLE 0260|
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).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Contact force delivered
time frame: Contact force information collected at the time of the procedures
Quantity and contiguity of ablation lesions
time frame: 3 months post procedure
Recurrence of atrial fibrillation
time frame: 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - atrial fibrillation - scheduled for catheter ablation Exclusion Criteria: - contraindication to magnetic resonance imaging - pregnancy - life expectancy of less than six months - participation in another trial that would conflict with this trial
|Official title||Manual vs Amigo SmartTouch Atrial Fibrillation Study|
|Principal investigator||G Andre Ng, MBChB, PhD|
|Description||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.|
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