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

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Trial Conditions
  • Cardiac Resynchronization Therapy
What is the purpose of this trial?

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.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

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.

Gender: Both
Steward Physician(s)
  • Kenneth Ellenbogen, MD
Trial Interventions
Device
  • Bi-ventricular lead placement
Physician Researcher

Investigator Name:

  • Kenneth Ellenbogen, MD

Other Information

Sponsor: Stereotaxis
Phase: Phase 4
Trial ID: NCT00370474
Volunteers:  Not Accepting Healthy Volunteers

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