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Completed

NCT Number: NCT01583855

Manual vs Amigo SmartTouch Atrial Fibrillation 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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glenfield Hospital, Groby Road

Leicester, LE3 9QP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter ablation for atrial fibrillation, manual

Procedure

Ablation for atrial fibrillation will be performed manually

Ablation using Amigo remote catheter system

Device

Atrial fibrillation ablation will be performed using the Amigo remote catheter system

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Registry information

Acronym: MAST-AF

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 24, 2012
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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