MAST-AF: Manual vs Amigo SmartTouch Atrial Fibrillation Study
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Manual ablation Patients will have their ablation performed manually. |
Procedure: Catheter ablation for atrial fibrillation, manual
Ablation for atrial fibrillation will be performed manually
|
| Active Comparator: Ablation using remote catheter system Ablation for atrial fibrillation using the Amigo remote catheter system |
Device: Ablation using Amigo remote catheter system
Atrial fibrillation ablation will be performed using the Amigo remote catheter system
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Glenfield Hospital, Groby Road | Leicester | United Kingdom | LE3 9QP |
Sponsors and Collaborators
- University of Leicester
Investigators
- Principal Investigator: G Andre Ng, MBChB, PhD, University of Leicester, UK
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0260