MAGNET CRT Feasibility - Efficiency of LV Lead Placement Comparing Conventional vs. Magnetic Guidance
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.
Cardiac Resynchronization Therapy
Device: Bi-ventricular lead placement
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-Center Assessment of Gain in Navigation Efficiency To Cardiac Resynchronization Therapy|
- The first primary endpoint for this trial is LV lead placement time defined as time from entry of the guidewire into the coronary sinus os to confirmed positioning of the lead tip at the target site
- The second primary endpoint will be time from introduction of the LVlead into the introducer sheath to positioning of the lead tip at the target site.
- Secondary endpoints include
- Skin to Skin time (Time of first skin incision to skin closure)
- Success in lead positioning to posterior-lateral location or other identified initial target or other identified initial target determined by 3-month lead-related complication free rate > 80%
- Percent of cases with stable lead placement as noted by appropriate sensing and pacing thresholds. by using a pacing system analyzer (PSA)
- peri-operatively and pulse generator post-operatively (mean 3-month:
- pacing threshold < 2.5 V, amplitude > 3/0 mV, pacing impedance
- > 300 Ώ)
- Procedural success, defined as the ability to complete the procedure.
- CC’s of contrast utilized for the procedure.
- Total procedure fluoroscopy time.
- LV lead placement fluoroscopy time.
- Total numbers of guidewires to complete
- LV lead placement.
- Guidewire-related adverse events.
- Procedural adverse events
|Study Start Date:||June 2006|
|Study Completion Date:||September 2006|
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.
|United States, Georgia|
|Northeast Georgia Heart Center|
|Gainesville, Georgia, United States, 30501|
|United States, Kentucky|
|Central Baptist Hospital|
|Lexington, Kentucky, United States, 40503|
|United States, Massachusetts|
|Caritus St. Elizabeth's Hospital|
|Boston, Massachusetts, United States, 02135|
|United States, Tennessee|
|Baptist Memphis Hospital|
|Memphis, Tennessee, United States, 38120|
|United States, Texas|
|Trinity Mother Frances|
|Tyler, Texas, United States, 75701|
|United States, Virginia|
|Medical Center of Virginia|
|Richmond, Virginia, United States, 23219|
|Principal Investigator:||Kenneth Ellenbogen, MD||Medical Center of Virginia, Richmond, VA|