Manual vs Amigo SmartTouch Atrial Fibrillation Study

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Catheter ablation for atrial fibrillation, manual; Device: Ablation using Amigo remote catheter system

• Registration Number: NCT01583855
• Lead Sponsor: University of Leicester

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.

Study Timeline

• Study First Submitted: 2012-02-27
• Study Start: 2012-03-01
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Primary Completion: 2015-02-28
• Study Completion: 2015-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual ablation	Catheter ablation for atrial fibrillation, manual	Patients will have their ablation performed manually.
Ablation using remote catheter system	Ablation using Amigo remote catheter system	Ablation for atrial fibrillation using the Amigo remote catheter system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Quantity and contiguity of ablation lesions	3 months post procedure	Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.

Trial Locations

Locations (1)

Glenfield Hospital, Groby Road; 🇬🇧 Leicester, United Kingdom