Atrial FibrillationMAST-AFNCT01583855
Manual vs Amigo SmartTouch Atrial Fibrillation Study
A study testing Catheter ablation for atrial fibrillation, manual and Ablation using Amigo remote catheter system in people with Atrial Fibrillation, run by University of Leicester at 1 site in United Kingdom.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation for atrial fibrillation, manual and Ablation using Amigo remote catheter system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2012to 28 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- atrial fibrillation
- scheduled for catheter ablation
Who cannot join
- contraindication to magnetic resonance imaging
- pregnancy
- life expectancy of less than six months
- participation in another trial that would conflict with this trial
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation for atrial fibrillation, manual, Ablation using Amigo remote catheter system
- Keywords
- Remote catheter ablation, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation for atrial fibrillation, manualProcedure or surgery
Ablation for atrial fibrillation will be performed manually
Ablation using Amigo remote catheter systemDevice
Atrial fibrillation ablation will be performed using the Amigo remote catheter system
| Study group | Role | What they receive |
|---|---|---|
| Manual ablation | Active comparator | Patients will have their ablation performed manually. Receives: Procedure: Catheter ablation for atrial fibrillation, manual |
| Ablation using remote catheter system | Active comparator | Ablation for atrial fibrillation using the Amigo remote catheter system Receives: Device: Ablation using Amigo remote catheter system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact force delivered
The contact force delivered by the catheter is measured and will be compared between the two groups.
Measured: Contact force information collected at the time of the procedures
Secondary outcomes (2)
Quantity and contiguity of ablation lesions
Cardiac magnetic resonance will be used to quantify and assess contiguity of ablation lesions.
Measured: 3 months post procedure
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study start1 Mar 2012
- Primary completion28 Feb 2015
- Study completion28 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G Andre Ng, MBChB, PhD, Principal investigator, University of Leicester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583855
- Sponsor's protocol ID
- 0260
- Acronym
- MAST-AF
- Status last verified
- Mar 2017
- First submitted
- 27 Feb 2012
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual vs Amigo SmartTouch Atrial Fibrillation Study
- ClinicalTrials.gov ID
- NCT01583855
- Acronym / sponsor ID
- MAST-AF / 0260
- Conditions
- Atrial Fibrillation
- Keywords
- Remote catheter ablation, Atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 1 Mar 2012
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 28 Feb 2015 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual ablation | Active comparator | Procedure: Catheter ablation for atrial fibrillation, manualPatients will have their ablation performed manually. |
| Ablation using remote catheter system | Active comparator | Device: Ablation using Amigo remote catheter systemAblation for atrial fibrillation using the Amigo remote catheter system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- atrial fibrillation
- scheduled for catheter ablation
Key exclusion criteria (4 listed)
- contraindication to magnetic resonance imaging
- pregnancy
- life expectancy of less than six months
- participation in another trial that would conflict with this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablation for atrial fibrillation, manualAblation for atrial fibrillation will be performed manually | Procedure or surgery | Manual ablation |
| Ablation using Amigo remote catheter systemAtrial fibrillation ablation will be performed using the Amigo remote catheter system | Device | Ablation using remote catheter system |
Primary outcome
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.
2 secondary outcomes
Quantity and contiguity of ablation lesions
Time frame: 3 months post procedure
Recurrence of atrial fibrillation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G Andre Ng, MBChB, PhD principal investigator
University of Leicester, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation for atrial fibrillation, manual and Ablation using Amigo remote catheter system in people with Atrial Fibrillation, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact force delivered (time frame: Contact force information collected at the time of the procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020; AzTrials last refreshed its copy on 2 Nov 2026.