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ClinicalTrials.gov record
Completed No phase listed Observational

3T MRI CIED Post-Approval Study

ClinicalTrials.gov ID: NCT02969395

Public ClinicalTrials.gov record NCT02969395. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 3:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02969395
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Medtronic
Industry
Enrollment
41 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2016
Primary completion
Oct 14, 2021
Completion
Oct 14, 2021
Last update posted
Aug 21, 2022

2016 – 2021

United States locations

U.S. sites
118
U.S. states
39
U.S. cities
118
Facility City State ZIP Site status
Not listed Birmingham Alabama
Not listed Anchorage Alaska
Not listed Chandler Arizona
Not listed Jonesboro Arkansas
Not listed Little Rock Arkansas
Not listed Bakersfield California
Not listed Chula Vista California
Not listed La Quinta California
Not listed Los Angeles California
Not listed Palm Springs California
Not listed Rancho Mirage California
Not listed Redwood City California
Not listed Salinas California
Not listed San Diego California
Not listed San Francisco California
Not listed Stanford California
Not listed Torrance California
Not listed Van Nuys California
Not listed Centennial Colorado
Not listed Colorado Springs Colorado
Not listed Denver Colorado
Not listed Lakewood Colorado
Not listed New Haven Connecticut
Not listed Newark Delaware
Not listed Washington D.C. District of Columbia
Not listed Bradenton Florida
Not listed Clearwater Florida
Not listed Davenport Florida
Not listed Davie Florida
Not listed Jacksonville Florida
Not listed Panama City Florida
Not listed Safety Harbor Florida
Not listed Sebastian Florida
Not listed Tampa Florida
Not listed Albany Georgia
Not listed Atlanta Georgia
Not listed Marietta Georgia
Not listed Coeur d'Alene Idaho
Not listed Chicago Illinois
Not listed Evansville Indiana
Not listed Indianapolis Indiana
Not listed West Des Moines Iowa
Not listed Kansas City Kansas
Not listed Edgewood Kentucky
Not listed Louisville Kentucky
Not listed Baton Rouge Louisiana
Not listed Shreveport Louisiana
Not listed Baltimore Maryland
Not listed Clinton Maryland
Not listed Hyattsville Maryland
Not listed Salisbury Maryland
Not listed Silver Spring Maryland
Not listed Takoma Park Maryland
Not listed Boston Massachusetts
Not listed Lansing Michigan
Not listed Marquette Michigan
Not listed Ypsilanti Michigan
Not listed Coon Rapids Minnesota
Not listed Minneapolis Minnesota
Not listed Robbinsdale Minnesota
Not listed Rochester Minnesota
Not listed Saint Cloud Minnesota
Not listed Saint Louis Park Minnesota
Not listed Saint Paul Minnesota
Not listed Hattiesburg Mississippi
Not listed Columbia Missouri
Not listed Kansas City Missouri
Not listed St Louis Missouri
Not listed Henderson Nevada
Not listed Eatontown New Jersey
Not listed Morristown New Jersey
Not listed Ocean Township New Jersey
Not listed Ridgewood New Jersey
Not listed Albuquerque New Mexico
Not listed Bay Shore New York
Not listed Garden City New York
Not listed Huntington New York
Not listed Manhasset New York
Not listed New Hyde Park New York
Not listed New York New York
Not listed Poughkeepsie New York
Not listed Staten Island New York
Not listed Suffern New York
Not listed The Bronx New York
Not listed Utica New York
Not listed Durham North Carolina
Not listed Raleigh North Carolina
Not listed Akron Ohio
Not listed Cincinnati Ohio
Not listed Cleveland Ohio
Not listed Columbus Ohio
Not listed Toledo Ohio
Not listed Oklahoma City Oklahoma
Not listed Portland Oregon
Not listed Allentown Pennsylvania
Not listed Bethlehem Pennsylvania
Not listed Danville Pennsylvania
Not listed Erie Pennsylvania
Not listed Lancaster Pennsylvania
Not listed Philadelphia Pennsylvania
Not listed Pittsburgh Pennsylvania
Not listed Wilkes-Barre Pennsylvania
Not listed Germantown Tennessee
Not listed Nashville Tennessee
Not listed Austin Texas
Not listed Fort Worth Texas
Not listed Houston Texas
Not listed Plano Texas
Not listed San Antonio Texas
Not listed The Woodlands Texas
Not listed Tyler Texas
Not listed Burlington Vermont
Not listed Arlington Virginia
Not listed Charlottesville Virginia
Not listed Falls Church Virginia
Not listed Spokane Washington
Not listed Madison Wisconsin
Not listed Milwaukee Wisconsin

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02969395, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 21, 2022 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02969395 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →