Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
|ClinicalTrials.gov Identifier: NCT01834872|
Recruitment Status : Unknown
Verified June 2013 by Tomas Datino, Instituto de Investigación Sanitaria Gregorio Marañón.
Recruitment status was: Active, not recruiting
First Posted : April 18, 2013
Last Update Posted : June 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Arrhythmias||Device: Amigo Device: Manual ablation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2014|
Ablation completed with Amigo
Active Comparator: Manual
Ablation completed with manual catheter
Device: Manual ablation
- Ablation Success [ Time Frame: 1 year ]
Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment
- Safety Endpoint [ Time Frame: 1 Year ]Any complications that could be attributed to the procedure during follow-up.
- Acute Ablation Success [ Time Frame: During Procedure ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834872
|Hospital General Universitario Gregorio Marañón|