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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Catheter Robotics, Inc.
Information provided by (Responsible Party):
Tomas Datino, Instituto de Investigación Sanitaria Gregorio Marañón
ClinicalTrials.gov Identifier:
NCT01834872
First received: April 4, 2013
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Arrhythmias
Device: Amigo
Device: Manual ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation

Resource links provided by NLM:


Further study details as provided by Instituto de Investigación Sanitaria Gregorio Marañón:

Primary Outcome Measures:
  • Ablation Success [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Global efficacy:

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


  • Safety Endpoint [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Any complications that could be attributed to the procedure during follow-up.


Secondary Outcome Measures:
  • Acute Ablation Success [ Time Frame: During Procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: During Procedure ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amigo
Ablation completed with Amigo
Device: Amigo
Active Comparator: Manual
Ablation completed with manual catheter
Device: Manual ablation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • NA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834872

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

No publications provided

Responsible Party: Tomas Datino, Dr., Instituto de Investigación Sanitaria Gregorio Marañón
ClinicalTrials.gov Identifier: NCT01834872     History of Changes
Other Study ID Numbers: Arenal - 001
Study First Received: April 4, 2013
Last Updated: June 11, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014