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Cardiac Resynchronization TherapyPhase 4NCT00370474

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

A Phase 4 study testing Bi-ventricular lead placement in people with Cardiac Resynchronization Therapy, run by Stereotaxis at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Resynchronization Therapy
What is being tested?
Bi-ventricular lead placement
Type of treatment
Medical device
How many people
27 participants
Where
6 sitesUnited States
Study dates
Jun 2006to Sep 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Caritus St. Elizabeth's Hospital

    Boston, Massachusetts, 02135

  • Northeast Georgia Heart Center

    Gainesville, Georgia, 30501

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Baptist Memphis Hospital

    Memphis, Tennessee, 38120

  • Medical Center of Virginia

    Richmond, Virginia, 23219

  • Trinity Mother Frances

    Tyler, Texas, 75701

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Bi-ventricular lead placement
Keywords
Bi-V lead, Magnetic Navigation, Cardiac Resynchronization Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bi-ventricular lead placementDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)

  1. Secondary endpoints include

  2. Skin to Skin time (Time of first skin incision to skin closure)

  3. 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%

  4. Percent of cases with stable lead placement as noted by appropriate sensing and pacing thresholds. by using a pacing system analyzer (PSA)

  5. peri-operatively and pulse generator post-operatively (mean 3-month:

  6. pacing threshold < 2.5 V, amplitude > 3/0 mV, pacing impedance

  7. > 300 Ώ)

  8. Procedural success, defined as the ability to complete the procedure.

  9. CC's of contrast utilized for the procedure.

  10. Total procedure fluoroscopy time.

  11. LV lead placement fluoroscopy time.

  12. Total numbers of guidewires to complete

  13. LV lead placement.

  14. Guidewire-related adverse events.

  15. Procedural adverse events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Study completionSep 2006

Why it stopped: Procedure protocol improved - study protocol became obsolete

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00370474
Sponsor's protocol ID
PM-CLIN 001
Status last verified
Jun 2007
First submitted
29 Aug 2006
Last updated
18 Jun 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bi-ventricular lead placement in people with Cardiac Resynchronization Therapy, run by Stereotaxis at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Procedure protocol improved - study protocol became obsolete). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00370474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2007.

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