Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

December 22, 2017 updated by: Medtronic

Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study

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).

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1847

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
  • Belgium
      • Hasselt, Belgium
  • Canada
      • Kingston, Canada
      • Toronto, Canada
    • Ontario
      • Ottawa, Ontario, Canada
    • Quebec
      • Ste-Foy, Quebec, Canada
  • France
      • Marseille, France
  • Italy
      • Reggio Emilia, Italy
      • Udine, Italy
  • Netherlands
      • Eindhoven, Netherlands
      • Rotterdam, Netherlands
  • Spain
      • Valencia, Spain
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Gilbert, Arizona, United States
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, 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
    • Colorado
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
    • Delaware
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bradenton, Florida, United States
      • Clearwater, Florida, United States
      • Jacksonville, Florida, United States
      • Melbourne, Florida, United States
      • Wellington, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Columbus, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Oak Lawn, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Salisbury, Maryland, United States
      • Silver Spring, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Grand Blanc, Michigan, United States
      • Marquette, Michigan, United States
      • Saginaw, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Robbinsdale, Minnesota, United States
      • Rochester, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, 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
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Huntington, New York, United States
      • Utica, New York, 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
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Florence, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Germantown, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Nashville, Tennessee, 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
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Fairfax, Virginia, United States
    • Washington
      • Olympia, Washington, United States
      • Spokane, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lead-related complication rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Investigators

  • Study Chair: 4196 LV Lead Chronic Performance Study Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4196 Chronic Performance

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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