Atrial Fibrillation
Conditions
Keywords
Remote catheter ablation, Atrial fibrillation
Brief summary
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).
Detailed 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.
Interventions
PROCEDURECatheter ablation for atrial fibrillation, manual
Ablation for atrial fibrillation will be performed manually
DEVICEAblation using Amigo remote catheter system
Atrial fibrillation ablation will be performed using the Amigo remote catheter system
Sponsors
University of Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact force delivered | Contact force information collected at the time of the procedures | The contact force delivered by the catheter is measured and will be compared between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity and contiguity of ablation lesions | 3 months post procedure | Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions. |
| Recurrence of atrial fibrillation | 1 year | Patients will be asked to attend office follow-up up to one year post procedure to assess for recurrence of atrial fibrillation. |
Countries
United Kingdom
Outcome results
None listed