Cardiac Resynchronization Therapy Clinical Trial
Official title:
Multi-Center Assessment of Gain in Navigation Efficiency To Cardiac Resynchronization Therapy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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