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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Instituto de Investigación Sanitaria Gregorio Marañón

Additional 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
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 August 28, 2014