Clinical trial NCT01076348: Model 4965 Post-Approval Study
Official title: Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Pacing
Bradycardia
Arrhythmia
Keywords: Epicardial
Pacing Lead
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 19 years or older implanted with Model 4965 Capsure Epi Lead.

Brief summary: Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

Detailed description: As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.

Eligibility criteria: Inclusion Criteria:

* Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB

AND one of the following (A, B, or C) must also apply:

A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.

B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:

* product is market-released
* complete implant and follow-up data, including product-related adverse events, are available
* subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.

Exclusion Criteria:

* Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
* Subjects who are, or will be inaccessible for follow-up at a SLS center
* Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
* Subjects with exclusion criteria required by local law (EMEA only)

Primary outcomes:
measure: Model 4965 Complication Free Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Downey
country: United States
state: California
city: East Palo Alto
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Salinas
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: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Oak Lawn
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Alexandria
country: United States
state: Louisiana
city: Baton Rouge
country: United States
state: Louisiana
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Grand Blanc
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Robbinsdale
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Browns Mills
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Ocean City
country: United States
state: New Jersey
city: Parlin
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Mineola
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Doylestown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Florence
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Chesapeake
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Bedford Park
country: Australia
state: South Australia
city: Linz
country: Austria
city: Vienna
country: Austria
city: Hasselt
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Copenhagen
country: Denmark
city: Marseille
country: France
city: Homburg/Saar
country: Germany
city: Catanzaro
country: Italy
city: Reggio Emilia
country: Italy
city: Udine
country: Italy
city: Eindhoven
country: Netherlands
city: Rotterdam
country: Netherlands
city: Belgrad
country: Serbia
city: Valencia
country: Spain
city: Skovde
country: Sweden
city: Zurich
country: Switzerland
Study officials:
affiliation: Medtronic
name: 4965 Post-Approval Study Clinical Trial Leader
role: STUDY_CHAIR
References: