Cardiac Rhythm DisorderNCT02969395

3T MRI CIED Post-Approval Study

An observational study of Cardiac Rhythm Disorder, run by Medtronic at 204 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Cardiac Rhythm Disorder
How many people: 41 participants
Where: 204 sitesin 22 countries
Study dates: Apr 2016to 15 Oct 2021
How long will I take part?: 5 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

204 sites in 22 countries.

Country

City, postcode or hospital

204 sites in 22 countries

United States118 sites

Study site
Akron, Ohio
Study site
Albany, Georgia
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Albuquerque, New Mexico
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Allentown, Pennsylvania
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Anchorage, Alaska
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Arlington, Virginia
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Atlanta, Georgia
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Austin, Texas
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Bakersfield, California
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Baltimore, Maryland
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Baton Rouge, Louisiana
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Bay Shore, New York
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Bethlehem, Pennsylvania
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Birmingham, Alabama
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Boston, Massachusetts
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Bradenton, Florida
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Burlington, Vermont
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Centennial, Colorado
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Chandler, Arizona
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Charlottesville, Virginia
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Chicago, Illinois
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Chula Vista, California
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Clinton, Maryland
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Coeur d'Alene, Idaho
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Colorado Springs, Colorado
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Columbia, Missouri
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Columbus, Ohio
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Coon Rapids, Minnesota
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Danville, Pennsylvania
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Davenport, Florida
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Davie, Florida
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Denver, Colorado
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Durham, North Carolina
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Eatontown, New Jersey
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Edgewood, Kentucky
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Erie, Pennsylvania
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Evansville, Indiana
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Falls Church, Virginia
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Fort Worth, Texas
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Garden City, New York
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Germantown, Tennessee
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Hattiesburg, Mississippi
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Henderson, Nevada
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Houston, Texas
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Huntington, New York
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Hyattsville, Maryland
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Indianapolis, Indiana
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Jacksonville, Florida
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Jonesboro, Arkansas
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Kansas City, Kansas
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Kansas City, Missouri
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La Quinta, California
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Lakewood, Colorado
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Lancaster, Pennsylvania
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Lansing, Michigan
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Little Rock, Arkansas
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Los Angeles, California
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Louisville, Kentucky
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Madison, Wisconsin
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Manhasset, New York
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Marietta, Georgia
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Marquette, Michigan
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Morristown, New Jersey
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Nashville, Tennessee
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New Haven, Connecticut
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New Hyde Park, New York
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New York, New York
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Newark, Delaware
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Ocean Township, New Jersey
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Oklahoma City, Oklahoma
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Palm Springs, California
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Panama City, Florida
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Plano, Texas
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Portland, Oregon
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Poughkeepsie, New York
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Raleigh, North Carolina
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Rancho Mirage, California
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Redwood City, California
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Ridgewood, New Jersey
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Robbinsdale, Minnesota
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Rochester, Minnesota
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Safety Harbor, Florida
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Saint Cloud, Minnesota
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Saint Louis Park, Minnesota
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Saint Paul, Minnesota
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Salinas, California
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Salisbury, Maryland
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San Antonio, Texas
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San Diego, California
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San Francisco, California
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Sebastian, Florida
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Shreveport, Louisiana
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Silver Spring, Maryland
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Spokane, Washington
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St Louis, Missouri
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Stanford, California
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Staten Island, New York
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Suffern, New York
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Takoma Park, Maryland
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Tampa, Florida
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The Bronx, New York
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The Woodlands, Texas
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Toledo, Ohio
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Torrance, California
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Tyler, Texas
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Utica, New York
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Van Nuys, California
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Washington D.C., District of Columbia
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West Des Moines, Iowa
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Wilkes-Barre, Pennsylvania
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Ypsilanti, Michigan

Other trials in United States

France11 sites

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Avignon
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Brest
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Clermont-Ferrand
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Dijon
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La Rochelle
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Metz-Tessy
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Montpellier
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Nantes
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Paris
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Pringy
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Saint-Priest-en-Jarez

Other trials in France

Japan11 sites

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Fuchū
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Hidaka
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Hirosaki
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Hiroshima
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Kawasaki
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Kitakyushu
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Kyoto
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Ōsaka-sayama
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Sapporo
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Toyoake
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Urasoe

Other trials in Japan

South Korea9 sites

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Busan
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Changwon
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Daegu
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Gangneung
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Gwangju
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Gyeonggi-do
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Incheon
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Seongnam-si
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Seoul

Other trials in South Korea

Spain9 sites

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A Coruña
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Granada
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Madrid
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Palma de Mallorca
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Salamanca
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Santa Cruz de Tenerife
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Santiago de Compostela
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Valencia
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Valladolid

Other trials in Spain

Germany7 sites

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Aachen
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Cologne
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Essen
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Hanover
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Homburg
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Tübingen
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Ulm

Other trials in Germany

Canada6 sites

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Calgary
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Kingston, Ontario
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Montreal
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Ottawa
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Sainte-Foy, Quebec
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Trois-Rivières

Other trials in Canada

Belgium5 sites

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Brussels
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Dinant
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Leuven
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Liège
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Yvoir

Other trials in Belgium

United Kingdom5 sites

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Birmingham
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Leicester
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Liverpool
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Manchester
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Middlesbrough

Other trials in United Kingdom

Italy4 sites

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Castrovillari
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Lecce
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Milan
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Udine

Other trials in Italy

Netherlands4 sites

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Eindhoven
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Maastricht
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Nieuwegein
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Rotterdam

Other trials in Netherlands

China3 sites

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Kunming
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Taiyuan
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Tianjin

Other trials in China

Switzerland3 sites

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Geneva
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Lausanne
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Zurich

Other trials in Switzerland

Denmark1 site

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Copenhagen

Other trials in Denmark

Greece1 site

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Athens

Other trials in Greece

Hungary1 site

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Budapest

Other trials in Hungary

Malaysia1 site

Study site
Kuala Lumpur

Other trials in Malaysia

Portugal1 site

Study site
Creixomil

Other trials in Portugal

Serbia1 site

Study site
Belgrade

Other trials in Serbia

Slovakia1 site

Study site
Košice

Other trials in Slovakia

Slovenia1 site

Study site
Ljubljana

Other trials in Slovenia

Sweden1 site

Study site
Skövde

Other trials in Sweden

About this study

Official title: Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices

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).

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)
Medical subject headings: Arrhythmias, Cardiac

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Patients will be followed for approximately 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201615 Oct 2021

First posted21 Nov 2016 (estimated)
Study startApr 2016
Primary completion15 Oct 2021
Study completion15 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiac Rhythm DisorderStudies of the same condition, open and under way.
More trials run by MedtronicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 41 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02969395
Sponsor's protocol ID: 3T
Status last verified: Aug 2022
First submitted: 10 Nov 2016
Last updated: 22 Aug 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
RecruitingPhase 2
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Arrhythmogenic Cardiomyopathy

All Cardiac Rhythm Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices
ClinicalTrials.gov ID: NCT02969395
Acronym / sponsor ID: 3T
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)
Study type: Observational
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: MedtronicIndustry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: 15 Oct 2021 (actual)
Study completion: 15 Oct 2021 (actual)
First posted: 21 Nov 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 5 Years

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
Time frame: Patients will be followed for approximately 5 years.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.

Related trials for Cardiac Rhythm Disorder

Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
RecruitingPhase 2
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Arrhythmogenic Cardiomyopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

204 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Rhythm Disorder, run by Medtronic at 204 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in United States, France, Japan, South Korea, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Patients will be followed for approximately 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02969395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.