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: June 4, 2014
Last verified: June 2014
  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 and is integrated within the Product Surveillance Registry (PAN Registry).


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval 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: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Model 4196 LV lead complication-free 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 past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
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
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
Austria
Linz, Austria
Belgium
Hasselt, Belgium
Canada, Ontario
Ottawa, Ontario, Canada
Canada, Quebec
Ste-Foy, Quebec, Canada
Canada
Kingston, Canada
Toronto, Canada
France
Marseille, France
Italy
Reggio Emilia, Italy
Udine, Italy
Netherlands
Eindhoven, Netherlands
Rotterdam, Netherlands
Spain
Valencia, Spain
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: June 4, 2014
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 August 27, 2014