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Accuracy and Safety Study of the Magnetecs CGCI System for Intracardiac Mapping

NCT01222156 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-10-18

No results posted yet for this study

Summary

The Magnetecs Catheter Guidance Control and Imaging (CGCI) system is a magnetic remote navigation system which is comprised of a magnetic chamber of eight electromagnets around the patient torso. The system can change the magnetic field almost instantaneously and enables almost real time manipulation of a special magnetic catheter (Maxwell mapping catheter) which results in accurate, repeatable, rapid and safe target acquisition within the four chambers of the human heart.

The trial is a prospective, non-randomized, clinical one designed to test the study hypotheses of (a) technical equivalence of the study device in comparison to other magnetic remote navigation systems, (b) performance equivalence or non-inferiority of the study device target acquisition capability compared to presently used catheter navigation techniques, and (c) safety equivalence or non-inferiority of the study device in comparison to catheter navigation devices using other navigation techniques.

Conditions

  • Tachycardia, Supraventricular
  • Tachycardia, Ventricular

Interventions

PROCEDURE

Remote magnetic navigation

Remote magnetic navigation of electrophysiology catheters to target intracardiac anatomical sites at mapping-ablation procedures in patients with cardiac arrhythmias

DEVICE

Magnetecs Catheter Guidance Control and Imaging system

Magnetecs Catheter Guidance Control and Imaging (CGCI) system

Sponsors & Collaborators

  • Magnetecs Corporation

    lead OTHER

Principal Investigators

  • Jose L Merino, MD, PhD · Hospital Universitario La Paz

  • Eli Gang, MD · Magnetecs, Corp

  • Vivek Y Reddy, MD · Mount Sinai Hospital, New York, USA

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222156 on ClinicalTrials.gov