Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00930904
First received: June 30, 2009
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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. This study is part of the Product Performance Platform (PPP).


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Lead-related complication rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Types of lead-related events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Percent of subjects with changes in electrode programming [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Percent of fractures with loss of function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Mean bipolar pacing threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1778
Study Start Date: June 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Lead survivability will be summarized.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients implanted with a 4196 LV Lead within the last 6 months. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Criteria

Inclusion Criteria:

  • Subject or appropriate legal guardian provides written informed consent and authorization for access to and use of health information (if applicable).
  • Complete implant and follow-up data, including Model 4196 lead-related events are available.

AND one of the following must apply:

  • Subject is within six months post-implant of a 4196 Model lead connected to a market released Cardiac Resynchronization Therapy (Cardiac Resynchronization Therapy-Pacemaker or Cardiac Resynchronization Therapy-Defibrillator) device. The Medtronic lead must be used for a pacing or sensing application.
  • Subject who participated in the Medtronic Attain Ability Model 4196 Left Ventricular Lead Pre-Market Study.

Exclusion Criteria:

  • Subject implanted at a non-participating site, and implant, follow-up data, including Model 4196 lead-related events are not available within 30 days from implant.
  • Subject who is, or will be inaccessible for follow-up at a study site.
  • Subject with exclusion criteria required by local law (Europe, Middle East or Africa only).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930904

  Hide Study Locations
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
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Bakersfield, California, United States
Bakersville, California, United States
Chula Vista, California, United States
Downey, California, United States
East Palo Alto, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Rancho Mirage, California, United States
Salinas, California, United States
San Diego, 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
Tallahassee, Florida, United States
Tampa, 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
Covington, Louisiana, United States
United States, Maryland
Salisbury, Maryland, United States
Silver Spring, Maryland, United States
Takoma Park, Maryland, United States
Towson, Maryland, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Lansing, Michigan, United States
Marquette, Michigan, United States
Saginaw, Michigan, United States
Ypsilanti, Michigan, United States
United States, Minnesota
Coon Rapids, Minnesota, United States
Minneapolis, Minnesota, United States
Robbinsdale, Minnesota, United States
Rochester, Minnesota, United States
St. Louis Park, Minnesota, United States
United States, Missouri
Columbia, Missouri, United States
Kansas City, Missouri, United States
Washington, Missouri, United States
United States, Nevada
Henderson, Nevada, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
Brown Mills, New Jersey, United States
Ocean, 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
Garden City, New York, United States
Huntington, New York, United States
Poughkeepsie, New York, United States
Rochester, 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
Raleigh, 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, South Dakota
Sioux Falls, South Dakota, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Kingsport, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
United States, Vermont
Burlington, Vermont, United States
United States, Virginia
Chesapeake, Virginia, United States
Falls Church, 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
Austria
Linz, Austria
Belgium
Hasselt, Belgium
Canada, Ontario
Ottawa, Ontario, Canada
Canada, Quebec
Ste-Foy, Quebec, Canada
Canada
Toronto, Canada
France
Marseille, France
Italy
Catanzaro, Italy
Reggio Emilia, Italy
Udine, Italy
Netherlands
Eindhoven, Netherlands
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: 4196 LV Lead Chronic Performance Study Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00930904     History of Changes
Other Study ID Numbers: 4196 Chronic Performance
Study First Received: June 30, 2009
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee
Italy: Ethics Committee
Denmark: Ethics Committee
France: Conseil National de l'Ordre des Médecins
Austria: Ethikkommission

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014