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Status:

TERMINATED

MAGNET CRT Feasibility - Efficiency of LV Lead Placement Comparing Conventional vs. Magnetic Guidance

Lead Sponsor:

Stereotaxis

Conditions:

Cardiac Resynchronization Therapy

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Magnetic navigation will permit delivery of the LV lead tip to a prospectively defined location more efficiently and in a higher proportion of patients than is possible with manual navigation.

Detailed Description

MAGNET CRT is designed to compare magnetic navigation to manual (i.e., traditional) navigation in placing an over-the-wire (OTW)left ventricle (LV) lead at a target site identified by the investigator...

Eligibility Criteria

Inclusion

  • Inclusion Criteria/Exclusion Criteria:
  • The patient is 18 years of age or older.
  • The patient is clinically indicated for left ventricular lead placement as part of a pacing or defibrillator system.
  • The patient may be safely exposed to magnetic fields that exist in Niobe® MNS laboratory.
  • The patient is not participating in any clinical trial or studies that would conflict with the guidewire navigation/LV lead implant protocol for this study.
  • The patient is not pregnant, and if of childbearing potential has completed a pregnancy test which resulted negative.
  • The patient does not have an implanted pacemaker or defibrillator, unless such device will be explanted or otherwise deactivated during this procedure.
  • The patient has no contraindications for contrast dye injection.
  • The patient's diastolic blood pressure is greater than 40 mm Hg.
  • In the opinion of the investigator, the patient's general health status does not preclude participation in the study.
  • In the opinion of the investigator, the patient is a reasonable candidate for participation in this study.
  • The patient is not expected to undergo a heart transplant in the next 6 months.
  • The patient does not have a mechanical triscupid heart valve.
  • The patient has not had a myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2006

    Estimated Enrollment :

    27 Patients enrolled

    Trial Details

    Trial ID

    NCT00370474

    Start Date

    June 1 2006

    End Date

    September 1 2006

    Last Update

    June 18 2007

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Northeast Georgia Heart Center

    Gainesville, Georgia, United States, 30501

    2

    Central Baptist Hospital

    Lexington, Kentucky, United States, 40503

    3

    Caritus St. Elizabeth's Hospital

    Boston, Massachusetts, United States, 02135

    4

    Baptist Memphis Hospital

    Memphis, Tennessee, United States, 38120