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NCT01834872 Clinical Trial

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

Arrhythmias Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01834872
Other study ID # Arenal - 001
Secondary ID
Status Unknown status
Phase Phase 4
First received April 4, 2013
Last updated June 11, 2013
Start date September 2012
Est. completion date March 2014

Study information
Verified date June 2013
Source Instituto de Investigación Sanitaria Gregorio Marañón
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 50
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Amigo

• Manual ablation

Locations
Country Name City State
Spain Hospital General Universitario Gregorio Marañón Madrid

Sponsors (2)
Lead Sponsor Collaborator
Instituto de Investigación Sanitaria Gregorio Marañón Catheter Robotics, Inc.

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ablation Success Global efficacy:
Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment		 1 year
Primary Safety Endpoint Any complications that could be attributed to the procedure during follow-up. 1 Year
Secondary Acute Ablation Success 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 During Procedure
Secondary Acute Safety Endpoint 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.		 During Procedure
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