Trials / Completed
CompletedNCT01583855
Manual vs Amigo SmartTouch Atrial Fibrillation Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- University of Leicester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Catheter ablation for atrial fibrillation, manual | Ablation for atrial fibrillation will be performed manually |
| DEVICE | Ablation using Amigo remote catheter system | Atrial fibrillation ablation will be performed using the Amigo remote catheter system |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2015-02-28
- Completion
- 2015-02-28
- First posted
- 2012-04-24
- Last updated
- 2020-01-30
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01583855. Inclusion in this directory is not an endorsement.