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

June 14, 2007 updated by: Stereotaxis

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritus St. Elizabeth's Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memphis Hospital
    • Texas
      • Tyler, Texas, United States, 75701
        • Trinity Mother Frances
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Medical Center of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stereotaxis

Investigators

  • Principal Investigator: Kenneth Ellenbogen, MD, Medical Center of Virginia, Richmond, VA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 29, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

August 31, 2006

Study Record Updates

Last Update Posted (Estimate)

June 18, 2007

Last Update Submitted That Met QC Criteria

June 14, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PM-CLIN 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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