Overview

This trial is active, not recruiting.

Condition arrhythmias
Treatments amigo, manual ablation
Phase phase 4
Sponsor Instituto de Investigación Sanitaria Gregorio Marañón
Collaborator Catheter Robotics, Inc.
Start date September 2012
End date March 2014
Trial size 50 participants
Trial identifier NCT01834872, Arenal - 001

Summary

The aim of this prospective observational study is to evaluate the performance of Amigo RCS in ablation procedures for most common arrhythmias as compared to a conventional manual approach.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ablation completed with Amigo
amigo
(Active Comparator)
Ablation completed with manual catheter
manual ablation

Primary Outcomes

Measure
Ablation Success
time frame: 1 year
Safety Endpoint
time frame: 1 Year

Secondary Outcomes

Measure
Acute Ablation Success
time frame: During Procedure
Acute Safety Endpoint
time frame: During Procedure

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation Exclusion Criteria: - NA

Additional Information

Official title Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Instituto de Investigación Sanitaria Gregorio Marañón.