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

June 11, 2013 updated by: Tomas Datino, Instituto de Investigación Sanitaria Gregorio Marañón
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Hospital General Universitario Gregorio Maranon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amigo
Ablation completed with Amigo
Device: Amigo
Active Comparator: Manual
Ablation completed with manual catheter
Device: Manual ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation Success
Time Frame: 1 year

Global efficacy:

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Ablation Success
Time Frame: 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
During Procedure
Acute Safety Endpoint
Time Frame: 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.
During Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria Gregorio Marañón

Collaborators

Catheter Robotics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arenal - 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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