Clinical trial NCT01638897: DF4 Connector System Post-Approval Study
Official title: DF4 Connector System Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Sudden Cardiac Death
Heart Failure
Keywords: ICD
CRTD
DF4
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 1778
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: DF4 Lead Related Complication Rate
timeFrame: Up to 5 Years
Secondary outcomes:
measure: Types of DF4 lead related events
timeFrame: Up to 5 years
measure: Bipolar pacing impedance (ohms)
timeFrame: 5 years
measure: High voltage impedance (ohms)
timeFrame: 5 years
measure: Pacing threshold (volts)
timeFrame: 5 years
measure: Sensing amplitude (millivolts)
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Gilbert
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Edgewood
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Hyattsville
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Robbinsdale
country: United States
state: Minnesota
city: Saint Louis Park
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Morristown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Garden City
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Olympia
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Kingston
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Nantes
country: France
Study officials:
References: