Clinical trial NCT01076374: MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
Official title: Medtronic Adapta/Versa/Sensia Long Term Reliability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
Bradycardia
Keywords: pacemaker
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 2927
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG.

Brief summary: The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

Detailed description: The rate of device malfunctions will be determined and a comparison to historical controls will be done.

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 must also apply:

* Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The Medtronic lead must be used for pacing, sensing or defibrillation application.
* Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to SLS
* Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of device malfunctions
timeFrame: 5 years
Secondary outcomes:
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: Downey
country: United States
state: California
city: East Palo Alto
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Redding
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state: California
city: Salinas
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state: California
city: San Diego
country: United States
state: California
city: Santa Rosa
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state: California
city: Torrance
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state: California
city: Van Nuys
country: United States
state: California
city: Colorado Springs
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state: Colorado
city: Denver
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: Jacksonville
country: United States
state: Florida
city: Melbourne
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state: Florida
city: Tampa
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state: Florida
city: Albany
country: United States
state: Georgia
city: Atlanta
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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: Evansville
country: United States
state: Indiana
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: 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: Covington
country: United States
state: Louisiana
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Towson
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state: Maryland
city: Worcester
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state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Saginaw
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state: Michigan
city: Ypsilanti
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state: Michigan
city: Coon Rapids
country: United States
state: Minnesota
city: Minneapolis
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state: Minnesota
city: Robbinsdale
country: United States
state: Minnesota
city: Rochester
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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: Washington
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state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Browns Mills
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: Garden City
country: United States
state: New York
city: Henderson
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
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: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
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: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
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: Plano
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: Tacoma
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Linz
country: Austria
city: Hasselt
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Copenhagen
country: Denmark
city: Marseille
country: France
city: Nantes
country: France
city: Homburg/Saar
country: Germany
city: Reggio Emilia
country: Italy
city: Udine
country: Italy
city: Eindhoven
country: Netherlands
city: Rotterdam
country: Netherlands
city: Belgrade
country: Serbia
city: Skövde
country: Sweden
city: Zürich
country: Switzerland
Study officials:
affiliation: Medtronic
name: nEw3 PAS Clinical Trial Leader
role: STUDY_CHAIR
References: