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Manual vs Amigo SmartTouch Atrial Fibrillation Study (MAST AF)

This study is currently recruiting participants.
Verified December 2012 by University of Leicester
Sponsor:
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT01583855
First received: February 27, 2012
Last updated: January 7, 2013
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Procedure: Catheter ablation for atrial fibrillation, manual
Device: Ablation using Amigo remote catheter system
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Manual vs Amigo SmartTouch Atrial Fibrillation Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leicester:

Primary Outcome Measures:
  • Contact force delivered [ Time Frame: Contact force information collected at the time of the procedures ] [ Designated as safety issue: No ]
    The contact force delivered by the catheter is measured and will be compared between the two groups.


Secondary Outcome Measures:
  • Quantity and contiguity of ablation lesions [ Time Frame: 3 months post procedure ] [ Designated as safety issue: No ]
    Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.

  • Recurrence of atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients will be asked to attend office follow-up up to one year post procedure to assess for recurrence of atrial fibrillation.


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583855

Contacts
Contact: G Andre Ng, MBChB,PhD +441162583297 gan1@le.ac.uk

Locations
United Kingdom
Glenfield Hospital, Groby Road Recruiting
Leicester, United Kingdom, LE3 9QP
Contact: G Andre Ng, MBChB, PhD     +441162583297        
Sponsors and Collaborators
University of Leicester
Investigators
Principal Investigator: G Andre Ng, MBChB, PhD University of Leicester, UK
  More Information

No publications provided

Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01583855     History of Changes
Other Study ID Numbers: UNOLE 0260
Study First Received: February 27, 2012
Last Updated: January 7, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2013