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

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ClinicalTrials.gov Identifier: NCT01834872
Recruitment Status : Unknown
Verified June 2013 by Tomas Datino, Instituto de Investigación Sanitaria Gregorio Marañón.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2013
Last Update Posted : June 13, 2013
Sponsor:
Collaborator:
Catheter Robotics, Inc.
Information provided by (Responsible Party):
Tomas Datino, 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.

Condition or disease Intervention/treatment Phase
Arrhythmias Device: Amigo Device: Manual ablation Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
Study Start Date : September 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

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



Primary Outcome Measures :
  1. Ablation Success [ Time Frame: 1 year ]

    Global efficacy:

    Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment


  2. Safety Endpoint [ Time Frame: 1 Year ]
    Any complications that could be attributed to the procedure during follow-up.


Secondary Outcome Measures :
  1. 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

  2. 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834872


Locations
Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Sponsors and Collaborators
Instituto de Investigación Sanitaria Gregorio Marañón
Catheter Robotics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tomas Datino, Dr., Instituto de Investigación Sanitaria Gregorio Marañón
ClinicalTrials.gov Identifier: NCT01834872     History of Changes
Other Study ID Numbers: Arenal - 001
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013