3T MRI CIED Post-Approval Study

August 19, 2022 updated by: Medtronic

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
      • Dinant, Belgium
      • Leuven, Belgium
      • Liège, Belgium
      • Yvoir, Belgium
  • Canada
      • Calgary, Canada
      • Montreal, Canada
      • Ottawa, Canada
      • Trois-Rivières, Canada
    • Ontario
      • Kingston, Ontario, Canada
    • Quebec
      • Sainte-Foy, Quebec, Canada
  • China
      • Kunming, China
      • Taiyuan, China
      • Tianjin, China
  • Denmark
      • Copenhagen, Denmark
  • France
      • Avignon, France
      • Brest, France
      • Clermont-Ferrand, France
      • Dijon, France
      • La Rochelle, France
      • Metz-Tessy, France
      • Montpellier, France
      • Nantes, France
      • Paris, France
      • Pringy, France
      • Saint-Priest-en-Jarez, France
  • Germany
      • Aachen, Germany
      • Essen, Germany
      • Hannover, Germany
      • Homburg, Germany
      • Köln, Germany
      • Tübingen, Germany
      • Ulm, Germany
  • Greece
      • Athens, Greece
  • Hungary
      • Budapest, Hungary
  • Italy
      • Castrovillari, Italy
      • Lecce, Italy
      • Milan, Italy
      • Udine, Italy
  • Japan
      • Fuchū, Japan
      • Hidaka, Japan
      • Hirosaki, Japan
      • Hiroshima City, Japan
      • Kawasaki, Japan
      • Kitakyushu, Japan
      • Kyoto, Japan
      • Sapporo, Japan
      • Toyoake, Japan
      • Urasoe, Japan
      • Ōsaka-sayama, Japan
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Changwon, Korea, Republic of
      • Daegu, Korea, Republic of
      • Gangneung, Korea, Republic of
      • Gwangju, Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seongnam-si, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Kuala Lumpur, Malaysia
  • Netherlands
      • Eindhoven, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
  • Portugal
      • Creixomil, Portugal
  • Serbia
      • Belgrad, Serbia
  • Slovakia
      • Košice, Slovakia
  • Slovenia
      • Ljubljana, Slovenia
  • Spain
      • Granada, Spain
      • La Coruña, Spain
      • Madrid, Spain
      • Palma De Mallorca, Spain
      • Salamanca, Spain
      • Santa Cruz De Tenerife, Spain
      • Santiago De Compostela, Spain
      • Valencia, Spain
      • Valladolid, Spain
  • Sweden
      • Skövde, Sweden
  • Switzerland
      • Geneva, Switzerland
      • Lausanne, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Birmingham, United Kingdom
      • Leicester, United Kingdom
      • Liverpool, United Kingdom
      • Manchester, United Kingdom
      • Middlesbrough, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Chandler, Arizona, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Chula Vista, California, United States
      • La Quinta, California, United States
      • Los Angeles, California, United States
      • Palm Springs, California, United States
      • Rancho Mirage, California, United States
      • Redwood City, California, United States
      • Salinas, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Stanford, California, United States
      • Torrance, California, United States
      • Van Nuys, California, United States
    • Colorado
      • Centennial, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Lakewood, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bradenton, Florida, United States
      • Clearwater, Florida, United States
      • Davenport, Florida, United States
      • Davie, Florida, United States
      • Jacksonville, Florida, United States
      • Panama City, Florida, United States
      • Safety Harbor, Florida, United States
      • Sebastian, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Albany, Georgia, United States
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
    • Idaho
      • Coeur d'Alene, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
    • Iowa
      • West Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Edgewood, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Clinton, Maryland, United States
      • Hyattsville, Maryland, United States
      • Salisbury, Maryland, United States
      • Silver Spring, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
      • Marquette, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Coon Rapids, Minnesota, United States
      • Minneapolis, Minnesota, United States
      • Robbinsdale, Minnesota, United States
      • Rochester, Minnesota, United States
      • Saint Cloud, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Mississippi
      • Hattiesburg, Mississippi, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nevada
      • Henderson, Nevada, United States
    • New Jersey
      • Eatontown, New Jersey, United States
      • Morristown, New Jersey, United States
      • Ocean Township, New Jersey, United States
      • Ridgewood, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Bay Shore, New York, United States
      • Bronx, New York, United States
      • Garden City, New York, United States
      • Huntington, New York, United States
      • Manhasset, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Poughkeepsie, New York, United States
      • Staten Island, New York, United States
      • Suffern, New York, United States
      • Utica, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Bethlehem, Pennsylvania, United States
      • Danville, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Wilkes-Barre, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
      • The Woodlands, Texas, United States
      • Tyler, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Arlington, Virginia, United States
      • Charlottesville, Virginia, United States
      • Falls Church, Virginia, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Patients will be followed for approximately 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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