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

This study has been terminated.
(Procedure protocol improved - study protocol became obsolete)
Sponsor:
Information provided by:
Stereotaxis
ClinicalTrials.gov Identifier:
NCT00370474
First received: August 29, 2006
Last updated: June 14, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Cardiac Resynchronization Therapy
Device: Bi-ventricular lead placement
Phase 4

Study Type: Interventional
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

Further study details as provided by Stereotaxis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 27
Study Start Date: June 2006
Study Completion Date: September 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370474

Locations
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
Sponsors and Collaborators
Stereotaxis
Investigators
Principal Investigator: Kenneth Ellenbogen, MD Medical Center of Virginia, Richmond, VA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00370474     History of Changes
Other Study ID Numbers: PM-CLIN 001
Study First Received: August 29, 2006
Last Updated: June 14, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Stereotaxis:
Bi-V lead
Magnetic Navigation
Cardiac Resynchronization Therapy

ClinicalTrials.gov processed this record on October 21, 2014