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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

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. Read more about this study

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

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.

204 sites in 22 countries

United States118 sites

  • Study site

    Akron, Ohio

  • Study site

    Albany, Georgia

  • Study site

    Albuquerque, New Mexico

  • Study site

    Allentown, Pennsylvania

  • Study site

    Anchorage, Alaska

  • Study site

    Arlington, Virginia

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bakersfield, California

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bay Shore, New York

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Bradenton, Florida

  • Study site

    Burlington, Vermont

  • Study site

    Centennial, Colorado

  • Study site

    Chandler, Arizona

  • Study site

    Charlottesville, Virginia

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Clinton, Maryland

  • Study site

    Coeur d'Alene, Idaho

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, Missouri

  • Study site

    Columbus, Ohio

  • Study site

    Coon Rapids, Minnesota

  • Study site

    Danville, Pennsylvania

  • Study site

    Davenport, Florida

  • Study site

    Davie, Florida

  • Study site

    Denver, Colorado

  • Study site

    Durham, North Carolina

  • Study site

    Eatontown, New Jersey

  • Study site

    Edgewood, Kentucky

  • Study site

    Erie, Pennsylvania

  • Study site

    Evansville, Indiana

  • Study site

    Falls Church, Virginia

  • Study site

    Fort Worth, Texas

  • Study site

    Garden City, New York

  • Study site

    Germantown, Tennessee

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Henderson, Nevada

  • Study site

    Houston, Texas

  • Study site

    Huntington, New York

  • Study site

    Hyattsville, Maryland

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    La Quinta, California

  • Study site

    Lakewood, Colorado

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Manhasset, New York

  • Study site

    Marietta, Georgia

  • Study site

    Marquette, Michigan

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Morristown, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New Hyde Park, New York

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Ocean Township, New Jersey

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Palm Springs, California

  • Study site

    Panama City, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Portland, Oregon

  • Study site

    Poughkeepsie, New York

  • Study site

    Raleigh, North Carolina

  • Study site

    Rancho Mirage, California

  • Study site

    Redwood City, California

  • Study site

    Ridgewood, New Jersey

  • Study site

    Robbinsdale, Minnesota

  • Study site

    Rochester, Minnesota

  • Study site

    Safety Harbor, Florida

  • Study site

    Saint Cloud, Minnesota

  • Study site

    Saint Louis Park, Minnesota

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salinas, California

  • Study site

    Salisbury, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Sebastian, Florida

  • Study site

    Shreveport, Louisiana

  • Study site

    Silver Spring, Maryland

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Staten Island, New York

  • Study site

    Suffern, New York

  • Study site

    Takoma Park, Maryland

  • Study site

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Study site

    The Woodlands, Texas

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Tyler, Texas

  • Study site

    Utica, New York

  • Study site

    Van Nuys, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Des Moines, Iowa

  • Study site

    Wilkes-Barre, Pennsylvania

  • Study site

    Ypsilanti, Michigan

Other trials in United States

France11 sites

  • Study site

    Avignon

  • Study site

    Brest

  • Study site

    Clermont-Ferrand

  • Study site

    Dijon

  • Study site

    La Rochelle

  • Study site

    Metz-Tessy

  • Study site

    Montpellier

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Pringy

  • Study site

    Saint-Priest-en-Jarez

Other trials in France

Japan11 sites

  • Study site

    Fuchū

  • Study site

    Hidaka

  • Study site

    Hirosaki

  • Study site

    Hiroshima

  • Study site

    Kawasaki

  • Study site

    Kitakyushu

  • Study site

    Kyoto

  • Study site

    Ōsaka-sayama

  • Study site

    Sapporo

  • Study site

    Toyoake

  • Study site

    Urasoe

Other trials in Japan

South Korea9 sites

  • Study site

    Busan

  • Study site

    Changwon

  • Study site

    Daegu

  • Study site

    Gangneung

  • Study site

    Gwangju

  • Study site

    Gyeonggi-do

  • Study site

    Incheon

  • Study site

    Seongnam-si

  • Study site

    Seoul

Other trials in South Korea

Spain9 sites

  • Study site

    A Coruña

  • Study site

    Granada

  • Study site

    Madrid

  • Study site

    Palma de Mallorca

  • Study site

    Salamanca

  • Study site

    Santa Cruz de Tenerife

  • Study site

    Santiago de Compostela

  • Study site

    Valencia

  • Study site

    Valladolid

Other trials in Spain

Germany7 sites

  • Study site

    Aachen

  • Study site

    Cologne

  • Study site

    Essen

  • Study site

    Hanover

  • Study site

    Homburg

  • Study site

    Tübingen

  • Study site

    Ulm

Other trials in Germany

Canada6 sites

  • Study site

    Calgary

  • Study site

    Kingston, Ontario

  • Study site

    Montreal

  • Study site

    Ottawa

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Trois-Rivières

Other trials in Canada

Belgium5 sites

  • Study site

    Brussels

  • Study site

    Dinant

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Yvoir

Other trials in Belgium

United Kingdom5 sites

  • Study site

    Birmingham

  • Study site

    Leicester

  • Study site

    Liverpool

  • Study site

    Manchester

  • Study site

    Middlesbrough

Other trials in United Kingdom

Italy4 sites

  • Study site

    Castrovillari

  • Study site

    Lecce

  • Study site

    Milan

  • Study site

    Udine

Other trials in Italy

Netherlands4 sites

  • Study site

    Eindhoven

  • Study site

    Maastricht

  • Study site

    Nieuwegein

  • Study site

    Rotterdam

Other trials in Netherlands

China3 sites

  • Study site

    Kunming

  • Study site

    Taiyuan

  • Study site

    Tianjin

Other trials in China

Switzerland3 sites

  • Study site

    Geneva

  • Study site

    Lausanne

  • Study site

    Zurich

Other trials in Switzerland

Denmark1 site

  • Study site

    Copenhagen

Other trials in Denmark

Greece1 site

  • Study site

    Athens

Other trials in Greece

Hungary1 site

  • Study site

    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).

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.

  1. 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.

  1. First posted21 Nov 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion15 Oct 2021
  4. Study completion15 Oct 2021

Resources

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

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