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| Name | Class |
|---|---|
| Catheter Robotics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amigo | Experimental | Ablation completed with Amigo |
|
| Manual | Active Comparator | Ablation completed with manual catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amigo | Device |
| ||
| Manual ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation Success | Global efficacy: Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment | 1 year |
| Safety Endpoint | Any complications that could be attributed to the procedure during follow-up. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24440330 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 10, 2015 | |
| Reset | Oct 8, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 10, 2015 | Oct 8, 2015 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| During Procedure |
| 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. | During Procedure |