Clinical trial NCT02243696: Protego DF4 Post Approval Registry
Official title: Protego DF4 Post Approval Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Implantable Defibrillator User
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-18
Enrollment: 1694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With No Protego DF4 Lead Adverse Event
timeFrame: Up to 4.5 years
measure: Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
timeFrame: Up to 4.5 years
Secondary outcomes:
measure: Protego DF4 Lead Pacing Threshold Measurement
timeFrame: Up to 4.5 years
measure: Protego DF4 Lead Shock Impedance
timeFrame: Up to 4.5 years
measure: Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
timeFrame: Up to 4.5 years
measure: Protego DF4 Lead Sensing
timeFrame: Up to 4.5 years
measure: Protego DF4 Lead Pacing Impedance
timeFrame: Up to 4.5 years
Other outcomes:
Locations:
city: Gadsden
country: United States
state: Alabama
city: Avondale
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Escondido
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Hawthorne
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Temecula
country: United States
state: California
city: Torrance
country: United States
state: California
city: Norwalk
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Alton
country: United States
state: Illinois
city: Aurora
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Schaumburg
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: Lake Charles
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Cumberland
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Rochester Hills
country: United States
state: Michigan
city: Wyoming
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Clifton
country: United States
state: New Jersey
city: Mineola
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Steubenville
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Lancaster
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Kingwood
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Chesapeake
country: United States
state: Virginia
city: Fredericksburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
References: