Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
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 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|
- Ablation Success [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
- 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.
|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)|
Ablation completed with Amigo
Active Comparator: Manual
Ablation completed with manual catheter
|Device: Manual ablation|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834872
|Hospital General Universitario Gregorio Marañón|