Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834872
|Hospital General Universitario Gregorio Marañón|