Manual vs Amigo SmartTouch Atrial Fibrillation Study
MAST-AF
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Mar 2012
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2015
CompletedJanuary 30, 2020
March 1, 2017
3 years
February 27, 2012
January 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Quantity and contiguity of ablation lesions
3 months post procedure
Recurrence of atrial fibrillation
1 year
Study Arms (2)
Manual ablation
ACTIVE COMPARATORPatients will have their ablation performed manually.
Ablation using remote catheter system
ACTIVE COMPARATORAblation for atrial fibrillation using the Amigo remote catheter system
Interventions
Ablation for atrial fibrillation will be performed manually
Atrial fibrillation ablation will be performed using the Amigo remote catheter system
Eligibility Criteria
You may qualify if:
- atrial fibrillation
- scheduled for catheter ablation
You may not qualify if:
- contraindication to magnetic resonance imaging
- pregnancy
- life expectancy of less than six months
- participation in another trial that would conflict with this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glenfield Hospital, Groby Road
Leicester, LE3 9QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
G Andre Ng, MBChB, PhD
University of Leicester, UK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2012
First Posted
April 24, 2012
Study Start
March 1, 2012
Primary Completion
February 28, 2015
Study Completion
February 28, 2015
Last Updated
January 30, 2020
Record last verified: 2017-03