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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual ablation | Active Comparator | Patients will have their ablation performed manually. |
|
| Ablation using remote catheter system | Active Comparator | Ablation for atrial fibrillation using the Amigo remote catheter system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation for atrial fibrillation, manual | Procedure | Ablation for atrial fibrillation will be performed manually |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G Andre Ng, MBChB, PhD | University of Leicester, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenfield Hospital, Groby Road | Leicester | LE3 9QP | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Ablation using Amigo remote catheter system | Device | Atrial fibrillation ablation will be performed using the Amigo remote catheter system |
|
Patients will be asked to attend office follow-up up to one year post procedure to assess for recurrence of atrial fibrillation.
| 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |