Manual vs Amigo SmartTouch Atrial Fibrillation Study

Study Overview
=================
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.

Official Title
-----------------
Manual vs Amigo SmartTouch Atrial Fibrillation Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Catheter ablation for atrial fibrillation, manual
* Device: Ablation using Amigo remote catheter system


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual ablation<br>Patients will have their ablation performed manually. | Procedure: Catheter ablation for atrial fibrillation, manual<br>* Ablation for atrial fibrillation will be performed manually<br>|
| Active Comparator: Ablation using remote catheter system<br>Ablation for atrial fibrillation using the Amigo remote catheter system | Device: Ablation using Amigo remote catheter system<br>* Atrial fibrillation ablation will be performed using the Amigo remote catheter system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact force delivered | The contact force delivered by the catheter is measured and will be compared between the two groups. | Contact force information collected at the time of the procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity and contiguity of ablation lesions | Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions. | 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote catheter ablation, Atrial fibrillation