Clinical trial NCT02969395: 3T MRI CIED Post-Approval Study
Official title: Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Rhythm Disorder
Keywords: 3T
Magnetic Resonance Imaging (MRI)
Implantable Cardioverter Defibrillator (ICD)
Implantable Pulse Generator (IPG)
Cardiac Resynchronization Therapy (CRT)
Cardiac Implantable Electronic Device (CIED)
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 41
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 qualifying Medtronic 3T MR Conditional CIED system. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Brief summary: The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).


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 qualifying Medtronic 3T MR Conditional CIED system

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: The proportion of patients implanted with an MR Conditional CIED System with a pre-MRI to post-MRI scan PCT measure change of >0.5 Volts following 3T MRI scan exposure.
timeFrame: Patients will be followed for approximately 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Chandler
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: La Quinta
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Redwood City
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: Stanford
country: United States
state: California
city: Torrance
country: United States
state: California
city: Van Nuys
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
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: Davenport
country: United States
state: Florida
city: Davie
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Sebastian
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Albany
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state: Georgia
city: Atlanta
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state: Georgia
city: Marietta
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state: Georgia
city: Coeur d'Alene
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state: Idaho
city: Chicago
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state: Illinois
city: Evansville
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state: Indiana
city: Indianapolis
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state: Indiana
city: West Des Moines
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state: Iowa
city: Kansas City
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state: Kansas
city: Edgewood
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state: Kentucky
city: Louisville
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state: Kentucky
city: Baton Rouge
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state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
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state: Maryland
city: Clinton
country: United States
state: Maryland
city: Hyattsville
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
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state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Marquette
country: United States
state: Michigan
city: Ypsilanti
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state: Michigan
city: Coon Rapids
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state: Minnesota
city: Minneapolis
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state: Minnesota
city: Robbinsdale
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city: Rochester
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state: Minnesota
city: Saint Cloud
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state: Minnesota
city: Saint Louis Park
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state: Minnesota
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city: Hattiesburg
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state: Mississippi
city: Columbia
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state: Missouri
city: Kansas City
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state: Missouri
city: Saint Louis
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state: Missouri
city: Henderson
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state: Nevada
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state: New Jersey
city: Morristown
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state: New Jersey
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state: New Jersey
city: Ridgewood
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state: New Jersey
city: Albuquerque
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state: New Mexico
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state: New York
city: Bronx
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state: New York
city: Garden City
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state: New York
city: Huntington
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Suffern
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
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state: North Carolina
city: Akron
country: United States
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city: Cleveland
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state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Bethlehem
country: United States
state: Pennsylvania
city: Danville
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: Wilkes-Barre
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
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: Tyler
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Arlington
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Falls Church
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Brussels
country: Belgium
city: Dinant
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Yvoir
country: Belgium
city: Kingston
country: Canada
state: Ontario
city: Sainte-Foy
country: Canada
state: Quebec
city: Calgary
country: Canada
city: Montreal
country: Canada
city: Ottawa
country: Canada
city: Trois-Rivières
country: Canada
city: Kunming
country: China
city: Taiyuan
country: China
city: Tianjin
country: China
city: Copenhagen
country: Denmark
city: Avignon
country: France
city: Brest
country: France
city: Clermont-Ferrand
country: France
city: Dijon
country: France
city: La Rochelle
country: France
city: Metz-Tessy
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Paris
country: France
city: Pringy
country: France
city: Saint-Priest-en-Jarez
country: France
city: Aachen
country: Germany
city: Essen
country: Germany
city: Hannover
country: Germany
city: Homburg
country: Germany
city: Köln
country: Germany
city: Tübingen
country: Germany
city: Ulm
country: Germany
city: Athens
country: Greece
city: Budapest
country: Hungary
city: Castrovillari
country: Italy
city: Lecce
country: Italy
city: Milan
country: Italy
city: Udine
country: Italy
city: Fuchū
country: Japan
city: Hidaka
country: Japan
city: Hirosaki
country: Japan
city: Hiroshima City
country: Japan
city: Kawasaki
country: Japan
city: Kitakyushu
country: Japan
city: Kyoto
country: Japan
city: Sapporo
country: Japan
city: Toyoake
country: Japan
city: Urasoe
country: Japan
city: Ōsaka-sayama
country: Japan
city: Busan
country: Korea, Republic of
city: Changwon
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gangneung
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seongnam-si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur
country: Malaysia
city: Eindhoven
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Creixomil
country: Portugal
city: Belgrad
country: Serbia
city: Košice
country: Slovakia
city: Ljubljana
country: Slovenia
city: Granada
country: Spain
city: La Coruña
country: Spain
city: Madrid
country: Spain
city: Palma De Mallorca
country: Spain
city: Salamanca
country: Spain
city: Santa Cruz De Tenerife
country: Spain
city: Santiago De Compostela
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Skövde
country: Sweden
city: Geneva
country: Switzerland
city: Lausanne
country: Switzerland
city: Zurich
country: Switzerland
city: Birmingham
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
Study officials:
References: