At a glance
ClinicalIndex Comparison RecordN/ACompleted· 181 enrolled
Drug / intervention
Amigo catheter robotdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies
In Brief
A clinical study evaluating Amigo catheter robot for Atrial Flutter and Ventricular Tachycardia. Completed, enrolled 181 participants across 12 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Flutter, Ventricular Tachycardia
CountriesUnited Kingdom, United States
CollaboratorsMedpace, Inc.
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionOct 2011
TodayJul 2026
First PostedJun 9, 2010
Enrollment StartJun 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.1 years ago
Interventions
Amigo catheter robotdevice
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.