Model 4195 Left Ventricular (LV) Lead Chronic Performance Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/15/2018
Start Date:March 2009
End Date:April 3, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study

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.

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

Patients who meet all of the following inclusion criteria and do not meet any of the
following exclusion criteria are eligible for enrollment.

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 with exclusion criteria required by local law

- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results
We found this trial at
63
sites
Clinical Trial Facility in Redding California
Redding, California
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Redding, CA
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Clinical Trial Facility in Albany Georgia
Albany, Georgia
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Albany, GA
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Clinical Trial Facility in Albuquerque New Mexico
Albuquerque, New Mexico
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Albuquerque, NM
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Clinical Trial Facility in Anchorage Alaska
Anchorage, Alaska
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Anchorage, AK
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Clinical Trial Facility in Austin Texas
Austin, Texas 78744
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Austin, TX
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Clinical Trial Facility in Baton Rouge Louisiana
Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Clinical Trial Facility in Boston Massachusetts
Boston, Massachusetts
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Boston, MA
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Clinical Trial Facility in Bradenton Florida
Bradenton, Florida 34205
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Bradenton, FL
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Clinical Trial Facility in Burlington Vermont
Burlington, Vermont 05401
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Burlington, VT
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Clinical Trial Facility in Calgary Alberta
Calgary, Alberta
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Calgary,
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Clinical Trial Facility in Chula Vista California
Chula Vista, California 91910
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Chula Vista, CA
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Clinical Trial Facility in Cincinnati Ohio
Cincinnati, Ohio
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Cincinnati, OH
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Clinical Trial Facility in Clearwater Florida
Clearwater, Florida 33756
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Clearwater, FL
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Clinical Trial Facility in Cleveland Ohio
Cleveland, Ohio
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Cleveland, OH
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Clinical Trial Facility in Colorado Springs Colorado
Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Clinical Trial Facility in Columbia Missouri
Columbia, Missouri 65201
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Columbia, MO
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Clinical Trial Facility in Columbus Ohio
Columbus, Ohio 43214
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Columbus, OH
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Clinical Trial Facility in Covington Louisiana
Covington, Louisiana 70433
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Covington, LA
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Dallas, TX
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Clinical Trial Facility in Des Moines Iowa
Des Moines, Iowa
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Des Moines, IA
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Clinical Trial Facility in Durham North Carolina
Durham, North Carolina
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Durham, NC
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Clinical Trial Facility in Edgewood Kentucky
Edgewood, Kentucky
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Edgewood, KY
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Clinical Trial Facility in Falls Church Virginia
Falls Church, Virginia 22042
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Falls Church, VA
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Clinical Trial Facility in Fargo North Dakota
Fargo, North Dakota 58122
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Fargo, ND
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Clinical Trial Facility in Fort Worth Texas
Fort Worth, Texas
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Fort Worth, TX
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Clinical Trial Facility in Germantown Tennessee
Germantown, Tennessee 38138
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Germantown, TN
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Clinical Trial Facility in Grand Blanc Michigan
Grand Blanc, Michigan 48439
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Grand Blanc, MI
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Clinical Trial Facility in Henderson Nevada
Henderson, Nevada
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Henderson, NV
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Houston, TX
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
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Indianapolis, IN
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Clinical Trial Facility in Jacksonville Florida
Jacksonville, Florida 32209
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Jacksonville, FL
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Clinical Trial Facility in Kansas City Kansas
Kansas City, Kansas
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Kansas City, KS
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Clinical Trial Facility in Kansas City Missouri
Kansas City, Missouri 64108
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Kansas City, MO
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Clinical Trial Facility in Kingsport Tennessee
Kingsport, Tennessee 37660
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Kingsport, TN
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Clinical Trial Facility in Lancaster Pennsylvania
Lancaster, Pennsylvania 17604
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Lancaster, PA
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Clinical Trial Facility in Louisville Kentucky
Louisville, Kentucky 40202
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Louisville, KY
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Clinical Trial Facility in Madison Wisconsin
Madison, Wisconsin 53792
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Madison, WI
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Clinical Trial Facility in Marietta Georgia
Marietta, Georgia 30060
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Marietta, GA
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Clinical Trial Facility in Marquette Michigan
Marquette, Michigan
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Marquette, MI
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Clinical Trial Facility in Melbourne Florida
Melbourne, Florida
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Melbourne, FL
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Clinical Trial Facility in Milwaukee Wisconsin
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in New Haven Connecticut
New Haven, Connecticut
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New Haven, CT
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in Newburgh Indiana
Newburgh, Indiana 47630
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Newburgh, IN
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Clinical Trial Facility in Olympia Washington
Olympia, Washington 98502
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Olympia, WA
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Clinical Trial Facility in Phoenix Arizona
Phoenix, Arizona
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Phoenix, AZ
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Clinical Trial Facility in Plano Texas
Plano, Texas 75024
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Plano, TX
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
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Portland, OR
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Clinical Trial Facility in Robbinsdale Minnesota
Robbinsdale, Minnesota
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Robbinsdale, MN
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Clinical Trial Facility in Rochester Minnesota
Rochester, Minnesota 55905
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Rochester, MN
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Clinical Trial Facility in Saint Louis Park Minnesota
Saint Louis Park, Minnesota
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Saint Louis Park, MN
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Clinical Trial Facility in Salinas California
Salinas, California 93901
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Salinas, CA
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Clinical Trial Facility in Salisbury Maryland
Salisbury, Maryland 21801
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Salisbury, MD
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Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
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San Antonio, TX
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Clinical Trial Facility in Scottsdale Arizona
Scottsdale, Arizona
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Scottsdale, AZ
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Clinical Trial Facility in Silver Spring Maryland
Silver Spring, Maryland
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Silver Spring, MD
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Clinical Trial Facility in Spokane Washington
Spokane, Washington
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Spokane, WA
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Clinical Trial Facility in Stanford California
Stanford, California 94305
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Stanford, CA
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Clinical Trial Facility in Takoma Park Maryland
Takoma Park, Maryland 20912
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Takoma Park, MD
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Clinical Trial Facility in Toledo Ohio
Toledo, Ohio 43608
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Toledo, OH
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Clinical Trial Facility in Torrance California
Torrance, California
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Torrance, CA
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Clinical Trial Facility in West Orange New Jersey
West Orange, New Jersey 07052
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West Orange, NJ
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