Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments catheter ablation for atrial fibrillation, manual, ablation using amigo remote catheter system
Phase phase 4
Sponsor University of Leicester
Start date April 2012
End date December 2015
Trial size 50 participants
Trial identifier NCT01583855, UNOLE 0260

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients will have their ablation performed manually.
catheter ablation for atrial fibrillation, manual
Ablation for atrial fibrillation will be performed manually
(Active Comparator)
Ablation for atrial fibrillation using the Amigo remote catheter system
ablation using amigo remote catheter system
Atrial fibrillation ablation will be performed using the Amigo remote catheter system

Primary Outcomes

Measure
Contact force delivered
time frame: Contact force information collected at the time of the procedures

Secondary Outcomes

Measure
Quantity and contiguity of ablation lesions
time frame: 3 months post procedure
Recurrence of atrial fibrillation
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Manual vs Amigo SmartTouch Atrial Fibrillation Study
Principal investigator G Andre Ng, MBChB, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Leicester.