Trials / Completed
CompletedNCT01139814
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- Catheter Robotics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Amigo catheter robot | The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter. |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2010-06-09
- Last updated
- 2013-04-11
- Results posted
- 2013-04-10
Locations
12 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01139814. Inclusion in this directory is not an endorsement.