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

Phase 4

• Conditions: Arrhythmias
• Interventions: Device: Amigo; Device: Manual ablation

• Registration Number: NCT01834872
• Lead Sponsor: Instituto de Investigación Sanitaria Gregorio Marañón

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-13
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amigo	Amigo	Ablation completed with Amigo
Manual	Manual ablation	Ablation completed with manual catheter

Primary Outcome Measures

Name	Time	Method
Ablation Success	1 year	Global efficacy: Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment
Safety Endpoint	1 Year	Any complications that could be attributed to the procedure during follow-up.

Secondary Outcome Measures

Name	Time	Method
Acute Ablation Success	During Procedure	Accessory pathway: Anterograde and retrograde conduction block through the accessory Pathway Atrial fibrillation: % patients with all PV disconnected circumferential ablation with electrical disconnection of all pulmonary veins Common-type atrial flutter: Bidirectional cavotricuspid isthmus block AVNRT/Ventricular tachycardia/other atrial arrhythmias: Arrhythmia termination / absence o induction
Acute Safety Endpoint	During Procedure	Procedure complications: Any complication during the electrophysiological procedure and 1 week post ablation that could be attributed to the procedure: Vascular complication, pericardial effusion/cardiac tamponade, heart failure, others.; The number of adverse events will be collected.

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain