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NCT01139814 · ClinicalTrials.gov registry record · NA

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

A NA study of Ventricular Tachycardia and Atrial Flutter, sponsored by Catheter Robotics.

Completed
Registry status
NA
Development phase
181
Enrollment target
12
Study locations

NCT01139814 is a NA study of Ventricular Tachycardia and Atrial Flutter that has completed, run by Catheter Robotics. The registered enrollment target is 181 participants, below the 282-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (36% lower). The trial reports 12 study locations across 11 states.

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The verdict

NCT01139814, a NA study of Ventricular Tachycardia and Atrial Flutter, has completed, sponsored by Catheter Robotics.

COMPLETED
Registry status
NA
Development phase
181 participants
Enrollment target
12
Study locations

Study 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 Studied

Ventricular Tachycardia Atrial Flutter

Interventions

  • DEVICE Amigo catheter robot

Study Locations (12)

California

  • Hoag Memorial Hospital Presbyterian - Newport Beach
  • Sequoia Hospital - Redwood City

Illinois

  • Northwestern Medical Center - Chicago

Iowa

  • Genesis Health, - Davenport

Louisiana

  • Ochsner Medical Center - New Orleans

Maryland

  • Johns Hopkins University - Baltimore

New Jersey

  • Gagnon Cardiovascular Institute/Morristown Memorial Hospital - Morristown

New York

  • Lenox Hill Hospital - New York

Pennsylvania

  • Lancaster Heart & Stroke Foundation - Lancaster

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2010-06
Est. Completion 2011-10
Phase NA

Sponsor

Catheter Robotics

1 total trials

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What the Registry Record Tells You About NCT01139814

The ClinicalTrials.gov registry entry for NCT01139814 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 282-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (36% lower). The listed sponsor is Catheter Robotics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Ventricular Tachycardia appearing as the primary indexed condition, and to 1 intervention - of which Amigo catheter robot is the first listed.

NCT01139814 reports 12 study locations spanning 11 distinct geographic areas - top geographies include California, Illinois, Iowa.

Frequently Asked Questions

What is clinical trial NCT01139814 about?

NCT01139814 is a clinical study titled "Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies". 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).

What is the current status of trial NCT01139814?

This trial is currently completed. It is a NA study. The enrollment target is 181 participants. The study started on 2010-06. Estimated completion is 2011-10.

What conditions does trial NCT01139814 study?

This clinical trial studies the following conditions: Ventricular Tachycardia, Atrial Flutter.

What interventions are being tested in trial NCT01139814?

The interventions under investigation include: Amigo catheter robot (DEVICE).

Who is sponsoring clinical trial NCT01139814?

This trial is sponsored by Catheter Robotics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01139814 being conducted?

This trial has 12 study locations across California, Illinois, Iowa, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.