CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Amigo™ Robotic Catheter Manipulation +1 moredevice
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.

Search/NCT02467179
NCT02467179N/ACompleted
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Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus

University of California, San Diego·interventional·Posted Jun 9, 2015·Updated Jun 27, 2019

In Brief

A clinical study evaluating Amigo™ Robotic Catheter Manipulation and Manual Catheter Manipulation for Atrial Fibrillation and Atrial Flutter. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of the CTI is standard treatment for patients with a history of atrial flutter, and those undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation are used in standard clinical practice at The University of California, San Diego (UCSD) for ablation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Flutter
CountriesUnited States
CollaboratorsCatheter Robotics, Inc.

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 9, 2015
Enrollment StartMar 1, 2015
Primary CompletionOct 30, 2017
Study CompletionMar 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.1 years ago

Interventions

Amigo™ Robotic Catheter Manipulationdevice

Ablation is a standard procedure that patients may undergo for the atrial flutter. In this study, this group will be assigned to robotic catheter manipulation.

Manual Catheter Manipulationdevice

Ablation is a standard procedure that patients may undergo for the atrial flutter. In this study, this group will be assigned to manual catheter manipulation.