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

Cardiac Resynchronization Therapy Clinical Trial

Official title:

Multi-Center Assessment of Gain in Navigation Efficiency To Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00370474
• Other study ID #: PM-CLIN 001
• Status: Terminated
• Phase: Phase 4
• First received: August 29, 2006
• Last updated: June 14, 2007
• Start date: June 2006
• Est. completion date: September 2006

Study information

• Verified date: June 2007
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria/Exclusion 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy

Intervention

Device:
• Bi-ventricular lead placement

Locations

Country	Name	City	State
United States	Caritus St. Elizabeth's Hospital	Boston	Massachusetts
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Baptist Memphis Hospital	Memphis	Tennessee
United States	Medical Center of Virginia	Richmond	Virginia
United States	Trinity Mother Frances	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Secondary endpoints include
Secondary	Skin to Skin time (Time of first skin incision to skin closure)
Secondary	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%
Secondary	Percent of cases with stable lead placement as noted by appropriate sensing and pacing thresholds. by using a pacing system analyzer (PSA)
Secondary	peri-operatively and pulse generator post-operatively (mean 3-month:
Secondary	pacing threshold < 2.5 V, amplitude > 3/0 mV, pacing impedance
Secondary	> 300 ?)
Secondary	Procedural success, defined as the ability to complete the procedure.
Secondary	CC’s of contrast utilized for the procedure.
Secondary	Total procedure fluoroscopy time.
Secondary	LV lead placement fluoroscopy time.
Secondary	Total numbers of guidewires to complete
Secondary	LV lead placement.
Secondary	Guidewire-related adverse events.
Secondary	Procedural adverse events