Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930904
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : December 27, 2017
Information provided by (Responsible Party):

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).

Condition or disease
Heart Failure

Detailed Description:
Model 4196 LV lead complication-free survivability will be summarized.

Study Type : Observational
Actual Enrollment : 1847 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study
Study Start Date : June 2009
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Primary Outcome Measures :
  1. Lead-related complication rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Types of lead-related events [ Time Frame: 5 years ]
  2. Percent of subjects with changes in electrode programming [ Time Frame: 5 Years ]
  3. Percent of fractures with loss of function [ Time Frame: 5 years ]
  4. Mean bipolar pacing threshold [ Time Frame: 1 year ]
  5. Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00930904

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Alaska
Anchorage, Alaska, United States
United States, Arizona
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Bakersfield, California, United States
Chula Vista, California, United States
Downey, California, United States
East Palo Alto, California, United States
Long Beach, California, United States
Salinas, California, United States
San Bernardino, California, United States
Torrance, California, United States
Van Nuys, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
Denver, Colorado, United States
United States, Delaware
Newark, Delaware, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Bradenton, Florida, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Wellington, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Columbus, Georgia, United States
Marietta, Georgia, United States
United States, Illinois
Oak Lawn, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Louisiana
Alexandria, Louisiana, United States
Baton Rouge, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
Salisbury, Maryland, United States
Silver Spring, Maryland, United States
Takoma Park, Maryland, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Grand Blanc, Michigan, United States
Marquette, Michigan, United States
Saginaw, Michigan, United States
Ypsilanti, Michigan, United States
United States, Minnesota
Robbinsdale, Minnesota, United States
Rochester, Minnesota, United States
United States, Missouri
Columbia, Missouri, United States
Kansas City, Missouri, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
Browns Mills, New Jersey, United States
Ocean City, New Jersey, United States
Parlin, New Jersey, United States
West Orange, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Huntington, New York, United States
Utica, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, North Dakota
Fargo, North Dakota, United States
United States, Ohio
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Erie, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Sayre, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Florence, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Amarillo, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
United States, Vermont
Burlington, Vermont, United States
United States, Virginia
Fairfax, Virginia, United States
United States, Washington
Olympia, Washington, United States
Spokane, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Linz, Austria
Hasselt, Belgium
Canada, Ontario
Ottawa, Ontario, Canada
Canada, Quebec
Ste-Foy, Quebec, Canada
Kingston, Canada
Toronto, Canada
Marseille, France
Reggio Emilia, Italy
Udine, Italy
Eindhoven, Netherlands
Rotterdam, Netherlands
Valencia, Spain
Sponsors and Collaborators
Study Chair: 4196 LV Lead Chronic Performance Study Team Medtronic

Responsible Party: Medtronic Identifier: NCT00930904     History of Changes
Other Study ID Numbers: 4196 Chronic Performance
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases