NCT01834872

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

1.5 years

First QC Date

April 4, 2013

Last Update Submit

June 11, 2013

Conditions

Arrhythmias

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Acute Ablation Success

    During Procedure

  • Acute Safety Endpoint

    During Procedure

Study Arms (2)

Amigo

EXPERIMENTAL

Ablation completed with Amigo

Device: Amigo

Manual

ACTIVE COMPARATOR

Ablation completed with manual catheter

Device: Manual ablation

Interventions

AmigoDEVICE
Amigo
Manual ablationDEVICE
Manual

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 24440330DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 18, 2013

Study Start

September 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

ES(1)