Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

NCT00930904 | Completed

• 1 other identifier: 4196 Chronic Performance
• Study Type: observational
• Target: 1,847
• Locations: 8 countries
• Sites: 103

Brief Summary

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Lead-related complication rate

  5 years

Secondary Outcomes (5)

• Types of lead-related events

  5 years

• Percent of subjects with changes in electrode programming

  5 Years

• Percent of fractures with loss of function

  5 years

• Mean bipolar pacing threshold

  1 year

• Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with a 4196 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 Ability Model 4196 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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (103)

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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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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 4196 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: June 30, 2009
• First Posted: July 2, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

FR (1); BE (1); IT (2); US (91); CA (4); NL (2); AU (1); ES (1)