Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation

Instituto de Investigación Sanitaria Gregorio Marañón

Status and phase: Unknown; Phase 4

Conditions: Arrhythmias

Treatments: Device: Manual ablation; Device: Amigo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01834872

Arenal - 001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation

Exclusion criteria

• NA

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Amigo

Experimental group

Description:

Ablation completed with Amigo

Treatment:

Device: Amigo

Manual

Active Comparator group

Description:

Ablation completed with manual catheter

Treatment:

Device: Manual ablation