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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 Oct 26, 2026, 10:16 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
Apr 2016 (Type not available)
Primary completion
Oct 15, 2021 (Actual)
Completion
Oct 15, 2021 (Actual)
Last update posted
Aug 22, 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 — —
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Not listed Shreveport Louisiana — —
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Not listed Robbinsdale Minnesota — —
Not listed Rochester Minnesota — —
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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 — —
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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 — —
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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 — —
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Not listed Plano Texas — —
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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 22, 2022 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02969395 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →