DF4 Connector System Post-Approval Study

March 18, 2019 updated by: Medtronic
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1778

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Kingston, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Quebec City, Quebec, Canada
      • Trois-Rivieres, Quebec, Canada
  • France
      • Nantes, France
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Gilbert, Arizona, United States
      • Scottsdale, Arizona, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Chula Vista, California, United States
      • Rancho Mirage, California, United States
      • Salinas, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Torrance, California, United States
      • Van Nuys, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Lakewood, 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
    • Georgia
      • Albany, Georgia, United States
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Edgewood, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Hyattsville, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
      • Marquette, Michigan, United States
    • Minnesota
      • Robbinsdale, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nevada
      • Henderson, Nevada, United States
    • New Jersey
      • Morristown, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Garden City, New York, United States
      • Huntington, New York, United States
      • New York, New York, United States
      • Poughkeepsie, New York, United States
      • Utica, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Plano, Texas, United States
      • The Woodlands, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Washington
      • Olympia, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, 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 intended to be implanted or are within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Description

Inclusion Criteria:

  • Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Subject is intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application

Exclusion Criteria:

  • Subject who is, or will be inaccessible for follow-up at a study site
  • Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
  • Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DF4 Lead Related Complication Rate
Time Frame: Up to 5 Years
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead
Up to 5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types of DF4 lead related events
Time Frame: Up to 5 years
Number of DF4 lead related events grouped by type
Up to 5 years
Bipolar pacing impedance (ohms)
Time Frame: 5 years
Summary statistics at 5 years post-implant will be reported.
5 years
High voltage impedance (ohms)
Time Frame: 5 years
Summary statistics at 5 years post-implant will be reported
5 years
Pacing threshold (volts)
Time Frame: 5 years
The pacing threshold is the minimum electrical stimulus needed to consistently depolarize the heart outside of the heart's refractory period. Summary statistics at 5 years post-implant will be reported.
5 years
Sensing amplitude (millivolts)
Time Frame: 5 years
The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant.
5 years

Collaborators and Investigators

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

Sponsor

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

January 1, 2012

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF4

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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