Manual vs Amigo SmartTouch Atrial Fibrillation Study

NCT ID: NCT01583855

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2015-02-28

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual ablation

Patients will have their ablation performed manually.

Group Type ACTIVE_COMPARATOR

Catheter ablation for atrial fibrillation, manual

Intervention Type PROCEDURE

Ablation for atrial fibrillation will be performed manually

Ablation using remote catheter system

Ablation for atrial fibrillation using the Amigo remote catheter system

Group Type ACTIVE_COMPARATOR

Ablation using Amigo remote catheter system

Intervention Type DEVICE

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

Interventions

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Catheter ablation for atrial fibrillation, manual

Ablation for atrial fibrillation will be performed manually

Intervention Type PROCEDURE

Ablation using Amigo remote catheter system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G Andre Ng, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester, UK

Locations

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Glenfield Hospital, Groby Road

Leicester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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0260

Identifier Type: -

Identifier Source: org_study_id

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