MedTrace Logo

Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies

NCT01139814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2013-04-11

Study results available
· View outcomes & findings →

Summary

The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).

Conditions

  • Atrial Flutter
  • Ventricular Tachycardia

Interventions

DEVICE

Amigo catheter robot

The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Catheter Robotics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

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 NCT01139814 on ClinicalTrials.gov