Manual vs Amigo SmartTouch Atrial Fibrillation Study (MAST-AF)

January 29, 2020 updated by: University of Leicester
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital, Groby Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual ablation
Patients will have their ablation performed manually.
Procedure: Catheter ablation for atrial fibrillation, manual
Ablation for atrial fibrillation will be performed manually
Active Comparator: Ablation using remote catheter system
Ablation for atrial fibrillation using the Amigo remote catheter system
Device: Ablation using Amigo remote catheter system
Atrial fibrillation ablation will be performed using the Amigo remote catheter system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contact force delivered
Time Frame: 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.
Contact force information collected at the time of the procedures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantity and contiguity of ablation lesions
Time Frame: 3 months post procedure
Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.
3 months post procedure
Recurrence of atrial fibrillation
Time Frame: 1 year
Patients will be asked to attend office follow-up up to one year post procedure to assess for recurrence of atrial fibrillation.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Investigators

  • Principal Investigator: G Andre Ng, MBChB, PhD, University of Leicester, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 28, 2015

Study Completion (Actual)

February 28, 2015

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

April 20, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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