Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
Recruitment status was Active, not recruiting
|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|