Manual vs Amigo SmartTouch Atrial Fibrillation Study

Atrial Fibrillation Clinical Trial

— MAST-AF  

Official title:

Manual vs Amigo SmartTouch Atrial Fibrillation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583855
• Other study ID #: 0260
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: February 28, 2015

Study information

• Verified date: March 2017
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 28, 2015
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Glenfield Hospital, Groby Road	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantity and contiguity of ablation lesions	Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.	3 months post procedure
Secondary	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