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Clinical Trials/NCT01834872
NCT01834872
Unknown
Phase 4

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

Instituto de Investigación Sanitaria Gregorio Marañón1 site in 1 country50 target enrollmentSeptember 2012
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ConditionsArrhythmias

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Arrhythmias
Sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
Enrollment
50
Locations
1
Primary Endpoint
Ablation Success
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
March 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
Responsible Party
Principal Investigator
Principal Investigator

Tomas Datino

Dr.

Instituto de Investigación Sanitaria Gregorio Marañón

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ablation Success

Time Frame: 1 year

Global efficacy: 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.

Secondary Outcomes

  • Acute Ablation Success(During Procedure)
  • Acute Safety Endpoint(During Procedure)

Study Sites (1)

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