Back to resultsSafety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
Primary Purpose
Arrhythmias
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Amigo
Manual ablation
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmias
Eligibility Criteria
Inclusion Criteria:
- Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation
Exclusion Criteria:
- NA
Sites / Locations
- Hospital General Universitario Gregorio Marañón
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amigo
Manual
Arm Description
Ablation completed with Amigo
Ablation completed with manual catheter
Outcomes
Primary Outcome Measures
Ablation Success
Global efficacy:
Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment
Safety Endpoint
Any complications that could be attributed to the procedure during follow-up.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT01834872
First Posted
April 4, 2013
Last Updated
June 11, 2013
Sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
Collaborators
Catheter Robotics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01834872
Brief Title
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
Official Title
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
Collaborators
Catheter Robotics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amigo
Arm Type
Experimental
Arm Description
Ablation completed with Amigo
Arm Title
Manual
Arm Type
Active Comparator
Arm Description
Ablation completed with manual catheter
Intervention Type
Device
Intervention Name(s)
Amigo
Intervention Type
Device
Intervention Name(s)
Manual ablation
Primary Outcome Measure Information:
Title
Ablation Success
Description
Global efficacy:
Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment
Time Frame
1 year
Title
Safety Endpoint
Description
Any complications that could be attributed to the procedure during follow-up.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Acute Ablation Success
Description
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
Time Frame
During Procedure
Title
Acute Safety Endpoint
Description
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.
Time Frame
During Procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation
Exclusion Criteria:
NA
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24440330
Citation
Datino T, Arenal A, Pelliza M, Hernandez-Hernandez J, Atienza F, Gonzalez-Torrecilla E, Avila P, Bravo L, Fernandez-Aviles F. Comparison of the safety and feasibility of arrhythmia ablation using the Amigo Robotic Remote Catheter System versus manual ablation. Am J Cardiol. 2014 Mar 1;113(5):827-31. doi: 10.1016/j.amjcard.2013.11.030. Epub 2013 Dec 12.
Results Reference
derived
Learn more about this trial
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
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