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Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
NCT01139814 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01139814
The ClinicalTrials.gov registry entry for NCT01139814 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catheter Robotics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01139814 reports 12 study locations spanning 11 distinct geographic areas — top geographies include California, Illinois, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01139814?
The interventions under investigation include: Amigo catheter robot (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01139814?
This trial is sponsored by Catheter Robotics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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