NCT00370474

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 18, 2007

Status Verified

June 1, 2007

First QC Date

August 29, 2006

Last Update Submit

June 14, 2007

Conditions

Cardiac Resynchronization Therapy

Keywords

Bi-V leadMagnetic NavigationCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • 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:

  • +10 more secondary outcomes

Interventions

Bi-ventricular lead placementDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • The patient is 18 years of age or older.
  • The patient is clinically indicated for left ventricular lead placement as part of a pacing or defibrillator system.
  • The patient may be safely exposed to magnetic fields that exist in Niobe® MNS laboratory.
  • 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.
  • The patient is not pregnant, and if of childbearing potential has completed a pregnancy test which resulted negative.
  • The patient does not have an implanted pacemaker or defibrillator, unless such device will be explanted or otherwise deactivated during this procedure.
  • The patient has no contraindications for contrast dye injection.
  • The patient's diastolic blood pressure is greater than 40 mm Hg.
  • In the opinion of the investigator, the patient's general health status does not preclude participation in the study.
  • In the opinion of the investigator, the patient is a reasonable candidate for participation in this study.
  • The patient is not expected to undergo a heart transplant in the next 6 months.
  • The patient does not have a mechanical triscupid heart valve.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Northeast Georgia Heart Center

Gainesville, Georgia, 30501, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Caritus St. Elizabeth's Hospital

Boston, Massachusetts, 02135, United States

Location

Baptist Memphis Hospital

Memphis, Tennessee, 38120, United States

Location

Trinity Mother Frances

Tyler, Texas, 75701, United States

Location

Medical Center of Virginia

Richmond, Virginia, 23219, United States

Location

Study Officials

  • Kenneth Ellenbogen, MD

    Medical Center of Virginia, Richmond, VA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2006

First Posted

August 31, 2006

Study Start

June 1, 2006

Study Completion

September 1, 2006

Last Updated

June 18, 2007

Record last verified: 2007-06

Locations

US(6)