Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation

NCT ID: NCT01834872

Last Updated: 2013-06-13

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

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The aim of this prospective observational study is to evaluate the performance of Amigo RCS in ablation procedures for most common arrhythmias as compared to a conventional manual approach.

Detailed Description

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Conditions

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Arrhythmias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amigo

Ablation completed with Amigo

Group Type EXPERIMENTAL

Amigo

Intervention Type DEVICE

Manual

Ablation completed with manual catheter

Group Type ACTIVE_COMPARATOR

Manual ablation

Intervention Type DEVICE

Interventions

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Amigo

Intervention Type DEVICE

Manual ablation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation

Exclusion Criteria

* NA
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catheter Robotics, Inc.

INDUSTRY

Sponsor Role collaborator

Instituto de Investigación Sanitaria Gregorio Marañón

OTHER

Sponsor Role lead

Responsible Party

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Tomas Datino

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Countries

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Spain

References

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Datino T, Arenal A, Pelliza M, Hernandez-Hernandez J, Atienza F, Gonzalez-Torrecilla E, Avila P, Bravo L, Fernandez-Aviles F. Comparison of the safety and feasibility of arrhythmia ablation using the Amigo Robotic Remote Catheter System versus manual ablation. Am J Cardiol. 2014 Mar 1;113(5):827-31. doi: 10.1016/j.amjcard.2013.11.030. Epub 2013 Dec 12.

Reference Type DERIVED
PMID: 24440330 (View on PubMed)

Other Identifiers

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Arenal - 001

Identifier Type: -

Identifier Source: org_study_id

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