Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

NCT ID: NCT00869921

Last Updated: 2018-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2018-04-03

Brief Summary

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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.

Detailed Description

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Model 4195 LV lead complication-free survivability will be summarized.

Conditions

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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4195 LV Lead Chronic Performance Study Team

Role: STUDY_CHAIR

Medtronic

Locations

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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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Countries

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United States Canada United Kingdom

Other Identifiers

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4195 Chronic Performance

Identifier Type: -

Identifier Source: org_study_id

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