Protego DF4 Post Approval Registry



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:September 2014
End Date:October 2021

Use our guide to learn which trials are right for you!

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


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
68
sites
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Chicago, IL
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Alton, IL
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Anderson, SC
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Aurora, IL
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Avondale, AZ
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Baltimore, MD
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Bangor, ME
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Brooksville, FL
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Burlington, VT
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Chesapeake, VA
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Cincinnati, OH
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Clifton, NJ
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Columbia, SC
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Corpus Christi, TX
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Cumberland, MD
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Daytona Beach, FL
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Detroit, MI
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Escondido, CA
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Fargo, ND
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Flint, MI
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Fort Wayne, IN
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Fort Worth, TX
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Fountain Valley, California 92708
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Fountain Valley, CA
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Fredericksburg, VA
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Gadsden, AL
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from
Glendale, AZ
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Greenville, South Carolina 29605
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Greenville, SC
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Hawthorne, CA
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Houston, TX
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Kingwood, TX
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Kissimmee, FL
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Lafayette, LA
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Lake Charles, LA
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Lancaster, South Carolina 29720
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Lancaster, SC
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from
Lansing, MI
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from
Lexington, KY
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Los Angeles, CA
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from
Miami, FL
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Middletown, OH
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Mineola, NY
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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from
New Smyrna Beach, FL
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Norfolk, VA
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from
Norwalk, CT
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Orlando, FL
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Owensboro, KY
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Peoria, AZ
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Philadelphia, PA
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Phoenix, AZ
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Rochester Hills, Michigan 48085
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Rochester Hills, MI
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Rock Hill, SC
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Saint Louis, MO
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Saint Petersburg, Florida 33713
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Saint Petersburg, FL
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San Antonio, TX
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Santa Barbara, California 93105
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Santa Barbara, CA
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Schaumburg, IL
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Seattle, WA
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Steubenville, OH
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Stony Brook, NY
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Temecula, CA
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Tomball, TX
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Torrance, CA
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Winston-Salem, NC
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Winter Park, FL
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from
Worcester, MA
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from
Wyoming, MI
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from
Ypsilanti, MI
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from
Zephyrhills, FL
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