Arrhythmias
Conditions
Brief summary
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.
Interventions
DEVICEAmigo
DEVICEManual ablation
Sponsors
Catheter Robotics, Inc.
Instituto de Investigación Sanitaria Gregorio Marañón
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ablation Success | 1 year | Global efficacy: Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment |
| Safety Endpoint | 1 Year | Any complications that could be attributed to the procedure during follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Ablation Success | 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 | 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. |
Countries
Spain
Outcome results
None listed