NCT00869921

Brief Summary

Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
3 countries

67 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

9.1 years

First QC Date

March 25, 2009

Last Update Submit

September 12, 2018

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Lead-related complication rate.

    Implant to 5 years post-implant.

Secondary Outcomes (1)

  • Types of Model 4195 lead-related events

    5 years post implant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with a 4195 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.

You may not qualify if:

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive an Attain StarFix Model 4195 LV lead
  • Patient within 30 day post implant enrollment window
  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (67)

Unknown Facility

Anchorage, Alaska, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Chula Vista, California, United States

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Redding, California, United States

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Salinas, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Colorado Springs, Colorado, United States

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New Haven, Connecticut, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Albany, Georgia, United States

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Marietta, Georgia, United States

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Indianapolis, Indiana, United States

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Newburgh, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Edgewood, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Salisbury, Maryland, United States

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Silver Spring, Maryland, United States

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Takoma Park, Maryland, United States

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Boston, Massachusetts, United States

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Grand Blanc, Michigan, United States

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Marquette, Michigan, United States

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Robbinsdale, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Henderson, Nevada, United States

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West Orange, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Lancaster, Pennsylvania, United States

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Germantown, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Falls Church, Virginia, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Calgary, Alberta, Canada

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Kingston, Ontario, Canada

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Ottawa, Ontario, Canada

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Québec, Quebec, Canada

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Middlesbrough, United Kingdom

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 4195 LV Lead Chronic Performance Study Team

    Medtronic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2009

Primary Completion

April 3, 2018

Study Completion

April 3, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

GB(1)US(62)CA(4)