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

NCT ID: NCT00370474

Last Updated: 2007-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-09-30

Brief Summary

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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

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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. This is a prospective, randomized, multicenter trial in which randomization (2:1, magnetic: manual navigation) will occur after the patient-specific target site is identified on two hardcopy x-ray images of the coronary venogram. The target area will be identified upon review of a venogram of the patient's coronary venous system taken during the current procedure.

Other variables such as navigating through the vasculature to a potential target site (especially if the path is tortuous), achieving good contact with the myocardium, providing repositioning if needed, countering heart motion, retrograde blood flow, and maintaining a stable delivery system during the release of the lead, are all determinants in the success of LV lead placement.

The Magnetic Navigation System (MNS) may thus aid in coronary venous vasculature navigation of guidewires for over-the-wire (OTW) left ventricular (LV) pacing lead placement by assisting in directing the tip of the guidewire, regardless of the tortuosity of a given patient's anatomy.

No investigational products will be used in the conduct of this study. The Niobe® Magnetic Navigation System and all Stereotaxis guidewires and other disposable products to be utilized have received US marketing clearance, and the protocol applications are within their specified intended use.

Conditions

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Cardiac Resynchronization Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bi-ventricular lead placement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The patient is 18 years of age or older.
2. The patient is clinically indicated for left ventricular lead placement as part of a pacing or defibrillator system.
3. The patient may be safely exposed to magnetic fields that exist in Niobe® MNS laboratory.
4. 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.
5. The patient is not pregnant, and if of childbearing potential has completed a pregnancy test which resulted negative.
6. The patient does not have an implanted pacemaker or defibrillator, unless such device will be explanted or otherwise deactivated during this procedure.
7. The patient has no contraindications for contrast dye injection.
8. The patient's diastolic blood pressure is greater than 40 mm Hg.
9. In the opinion of the investigator, the patient's general health status does not preclude participation in the study.
10. In the opinion of the investigator, the patient is a reasonable candidate for participation in this study.
11. The patient is not expected to undergo a heart transplant in the next 6 months.
12. The patient does not have a mechanical triscupid heart valve.
13. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stereotaxis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kenneth Ellenbogen, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center of Virginia, Richmond, VA

Locations

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Northeast Georgia Heart Center

Gainesville, Georgia, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Caritus St. Elizabeth's Hospital

Boston, Massachusetts, United States

Site Status

Baptist Memphis Hospital

Memphis, Tennessee, United States

Site Status

Trinity Mother Frances

Tyler, Texas, United States

Site Status

Medical Center of Virginia

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PM-CLIN 001

Identifier Type: -

Identifier Source: org_study_id