Protego DF4 Post Approval Registry

NCT02243696 | Terminated Results

• 1 other identifier: P980023/S057
• Study Type: observational
• Target: 1,694
• Locations: 1 country
• Sites: 68

Brief Summary

The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.

Conditions

Implantable Defibrillator User

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With No Protego DF4 Lead Adverse Event

  Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.

  Up to 4.5 years

• Protego DF4 Lead Safety-Individual Adverse Event-Free Rate

  Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.

  Up to 4.5 years

Secondary Outcomes (5)

• Protego DF4 Lead Pacing Threshold Measurement

  Up to 4.5 years

• Protego DF4 Lead Shock Impedance

  Up to 4.5 years

• Percentage of Subjects With no Adverse Events Excluded From Primary Objectives

  Up to 4.5 years

• Protego DF4 Lead Sensing

  Up to 4.5 years

• Protego DF4 Lead Pacing Impedance

  Up to 4.5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

You may qualify if:

• Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead
• Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies
• Able to understand the nature of the registry and provide informed consent
• Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up
• Age greater than or equal to 18 years

You may not qualify if:

• Enrolled in any investigational cardiac device trial
• Planned cardiac surgical procedures or interventional measures within the next 6 months
• Expected to receive heart transplantation or ventricular assist device within 1 year
• Life expectancy of less than 1 year
• Presence of another life-threatening, underlying illness separate from their cardiac disorder
• Patients reporting pregnancy at the time of enrollment

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (68)

Unknown Facility

Gadsden, Alabama, United States

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Avondale, Arizona, United States

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Glendale, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Escondido, California, United States

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Fountain Valley, California, United States

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Hawthorne, California, United States

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Los Angeles, California, United States

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Santa Barbara, California, United States

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Temecula, California, United States

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Torrance, California, United States

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Norwalk, Connecticut, United States

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Brooksville, Florida, United States

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Daytona Beach, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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New Smyrna Beach, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Winter Park, Florida, United States

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Zephyrhills, Florida, United States

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Alton, Illinois, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Schaumburg, Illinois, United States

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Fort Wayne, Indiana, United States

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Lexington, Kentucky, United States

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Owensboro, Kentucky, United States

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Lafayette, Louisiana, United States

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Lake Charles, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Cumberland, Maryland, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Flint, Michigan, United States

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Lansing, Michigan, United States

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Rochester Hills, Michigan, United States

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Wyoming, Michigan, United States

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Ypsilanti, Michigan, United States

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St Louis, Missouri, United States

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Clifton, New Jersey, United States

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Mineola, New York, United States

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Stony Brook, New York, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Middletown, Ohio, United States

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Steubenville, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Lancaster, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Rock Hill, South Carolina, United States

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Corpus Christi, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Kingwood, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Burlington, Vermont, United States

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Chesapeake, Virginia, United States

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Fredericksburg, Virginia, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Results Point of Contact

• Title: Clinical Studies Engineer Manager
• Organization: BIOTRONIK, Inc.

crystal.miller@biotronik.com

1-800-547-0394

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 18, 2014
• Study Start: September 27, 2014
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: June 22, 2020
• Results First Posted: April 22, 2020

Record last verified: 2020-06

Locations

US (68)