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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: Completed NA study of Ventricular Tachycardia and Atrial Flutter, sponsored by Catheter Robotics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT01139814 record still lists
NCT01139814 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 282-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (36% lower).
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 lists 12 locations in 11 states (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.
Learn More About Clinical Trials
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Where NCT01139814's enrollment target sits among peer trials
181 10th of 28 higher than 19 of 28 other Ventricular Tachycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ventricular Tachycardia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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