DF4 Connector System Post-Approval Study

NCT01638897 | Completed

• 1 other identifier: DF4
• Study Type: observational
• Target: 1,778
• Locations: 3 countries
• Sites: 78

Brief Summary

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.

Conditions

Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death; Heart Failure

Keywords

ICD; CRTD; DF4

Outcome Measures

Primary Outcomes (1)

• DF4 Lead Related Complication Rate

  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 Outcomes (5)

• Types of DF4 lead related events

  Up to 5 years

• Bipolar pacing impedance (ohms)

  5 years

• High voltage impedance (ohms)

  5 years

• Pacing threshold (volts)

  5 years

• Sensing amplitude (millivolts)

  5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subject who is, or will be inaccessible for follow-up at a study site
• Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable

Sponsors & Collaborators

• Medtronic: lead

Study Sites (78)

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Gilbert, Arizona, United States

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Scottsdale, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Chula Vista, California, United States

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Rancho Mirage, California, United States

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Salinas, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Torrance, California, United States

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Van Nuys, California, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Albany, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Edgewood, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Hyattsville, Maryland, United States

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Takoma Park, Maryland, United States

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Worcester, Massachusetts, United States

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Lansing, Michigan, United States

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Marquette, Michigan, United States

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Robbinsdale, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Saint Paul, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Morristown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Garden City, New York, United States

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Huntington, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Utica, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Allentown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Germantown, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Plano, Texas, United States

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The Woodlands, Texas, United States

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Burlington, Vermont, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Calgary, Alberta, Canada

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Kingston, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Nantes, France

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MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 12, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

CA (5); FR (1); US (72)