Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

NCT ID: NCT00930904

Last Updated: 2017-12-27

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

1847 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2017-04-30

Brief Summary

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The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Detailed Description

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Model 4196 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 Ability Model 4196 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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4196 LV Lead Chronic Performance Study Team

Role: STUDY_CHAIR

Medtronic

Locations

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Chula Vista, California, United States

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Downey, California, United States

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East Palo Alto, California, United States

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Long Beach, California, United States

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Salinas, California, United States

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San Bernardino, California, United States

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Torrance, California, United States

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Van Nuys, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, 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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Wellington, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Marietta, Georgia, United States

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Oak Lawn, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, 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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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Alexandria, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, 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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Worcester, Massachusetts, United States

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Grand Blanc, Michigan, United States

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Marquette, Michigan, United States

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Saginaw, Michigan, United States

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Ypsilanti, Michigan, United States

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Robbinsdale, Minnesota, United States

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Rochester, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Lebanon, New Hampshire, United States

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Browns Mills, New Jersey, United States

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Ocean City, New Jersey, United States

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Parlin, New Jersey, 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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Huntington, New York, United States

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Utica, New York, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Akron, Ohio, 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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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Florence, South Carolina, United States

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Chattanooga, Tennessee, 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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Amarillo, Texas, 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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San Antonio, Texas, United States

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The Woodlands, Texas, United States

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Burlington, Vermont, United States

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Fairfax, 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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Linz, , Austria

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Hasselt, , Belgium

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Ottawa, Ontario, Canada

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Ste-Foy, Quebec, Canada

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Kingston, , Canada

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Toronto, , Canada

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Marseille, , France

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Reggio Emilia, , Italy

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Udine, , Italy

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Eindhoven, , Netherlands

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Rotterdam, , Netherlands

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Valencia, , Spain

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Countries

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United States Austria Belgium Canada France Italy Netherlands Spain

Other Identifiers

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4196 Chronic Performance

Identifier Type: -

Identifier Source: org_study_id