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Manual vs Amigo SmartTouch Atrial Fibrillation Study

NCT01583855 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-30

No results posted yet for this study

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).

Conditions

Interventions

PROCEDURE

Catheter ablation for atrial fibrillation, manual

Ablation for atrial fibrillation will be performed manually

DEVICE

Ablation using Amigo remote catheter system

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

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Principal Investigators

  • G Andre Ng, MBChB, PhD · University of Leicester, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-01
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583855 on ClinicalTrials.gov