Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation

• Sponsor: Instituto de Investigación Sanitaria Gregorio Marañón (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01834872
• Collaborator: Catheter Robotics, Inc. (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmias	Device: Amigo; Device: Manual ablation	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Mar 1, 2014
• Anticipated Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amigo Ablation completed with Amigo	Device: Amigo
Active Comparator: Manual Ablation completed with manual catheter	Device: Manual ablation

Outcome Measures

Primary Outcome Measures

1. Ablation Success [1 year]

   Global efficacy: Recurrence rate Re-do procedures Proportion of patients under anti arrhythmic treatment

2. Safety Endpoint [1 Year]

   Any complications that could be attributed to the procedure during follow-up.

Secondary Outcome Measures

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients referred to our electrophysiology laboratory to treat any type of arrhythmia with catheter ablation

Exclusion Criteria:

• NA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General Universitario Gregorio Marañón	Madrid		Spain

Sponsors and Collaborators

• Instituto de Investigación Sanitaria Gregorio Marañón
• Catheter Robotics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tomas Datino, Dr., Instituto de Investigación Sanitaria Gregorio Marañón
• ClinicalTrials.gov Identifier: NCT01834872
• Other Study ID Numbers: Arenal - 001
• First Posted: Apr 18, 2013
• Last Update Posted: Jun 13, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Jun 13, 2013