Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370474
Status:
TERMINATED
Last Update Posted:
2007-06-18
First Post:
2006-08-29
Brief Title:
MAGNET CRT Feasibility - Efficiency of LV Lead Placement Comparing Conventional vs Magnetic Guidance
Sponsor:
Stereotaxis
Organization:
Stereotaxis
Study Overview
Official Title:
Multi-Center Assessment of Gain in Navigation Efficiency To Cardiac Resynchronization Therapy
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Procedure protocol improved - study protocol became obsolete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie traditional navigation in placing an over-the-wire OTWleft ventricle LV lead at a target site identified by the investigator This is a prospective randomized multicenter trial in which randomization 21 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 patients 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None