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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583855
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : May 9, 2018
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter ablation for atrial fibrillation, manual Device: Ablation using Amigo remote catheter system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Manual vs Amigo SmartTouch Atrial Fibrillation Study
Study Start Date : March 1, 2012
Actual Primary Completion Date : February 28, 2015
Actual Study Completion Date : February 28, 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583855

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United Kingdom
Glenfield Hospital, Groby Road
Leicester, United Kingdom, LE3 9QP
Sponsors and Collaborators
University of Leicester
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Principal Investigator: G Andre Ng, MBChB, PhD University of Leicester, UK

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Responsible Party: University of Leicester Identifier: NCT01583855     History of Changes
Other Study ID Numbers: UNOLE 0260
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: March 2017

Keywords provided by University of Leicester:
Remote catheter ablation
Atrial fibrillation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes