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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Catheter ablation for atrial fibrillation, manual
Ablation using Amigo remote catheter system
Sponsored by
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Remote catheter ablation, Atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glenfield Hospital, Groby Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Manual ablation

Ablation using remote catheter system

Arm Description

Patients will have their ablation performed manually.

Ablation for atrial fibrillation using the Amigo remote catheter system

Outcomes

Primary Outcome Measures

Contact force delivered
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
Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.
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.

Full Information

First Posted
February 27, 2012
Last Updated
January 29, 2020
Sponsor
University of Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT01583855
Brief Title
Manual vs Amigo SmartTouch Atrial Fibrillation Study
Acronym
MAST-AF
Official Title
Manual vs Amigo SmartTouch Atrial Fibrillation Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (undefined)
Primary Completion Date
February 28, 2015 (Actual)
Study Completion Date
February 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leicester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Remote catheter ablation, Atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual ablation
Arm Type
Active Comparator
Arm Description
Patients will have their ablation performed manually.
Arm Title
Ablation using remote catheter system
Arm Type
Active Comparator
Arm Description
Ablation for atrial fibrillation using the Amigo remote catheter system
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation for atrial fibrillation, manual
Intervention Description
Ablation for atrial fibrillation will be performed manually
Intervention Type
Device
Intervention Name(s)
Ablation using Amigo remote catheter system
Intervention Description
Atrial fibrillation ablation will be performed using the Amigo remote catheter system
Primary Outcome Measure Information:
Title
Contact force delivered
Description
The contact force delivered by the catheter is measured and will be compared between the two groups.
Time Frame
Contact force information collected at the time of the procedures
Secondary Outcome Measure Information:
Title
Quantity and contiguity of ablation lesions
Description
Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.
Time Frame
3 months post procedure
Title
Recurrence of atrial fibrillation
Description
Patients will be asked to attend office follow-up up to one year post procedure to assess for recurrence of atrial fibrillation.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G Andre Ng, MBChB, PhD
Organizational Affiliation
University of Leicester, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glenfield Hospital, Groby Road
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Manual vs Amigo SmartTouch Atrial Fibrillation Study

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