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3T MRI CIED Post-Approval Study

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ClinicalTrials.gov Identifier: NCT02969395
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief 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. 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).

Condition or disease
Cardiac Rhythm Disorder

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices
Study Start Date : April 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021



Primary Outcome Measures :
  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. [ Time Frame: Patients will be followed for approximately 5 years. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969395


Contacts
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Contact: Medtronic Product Surveillance Registry rs.productsurveillanceregistry@medtronic.com

Locations
Show Show 138 study locations
Sponsors and Collaborators
Medtronic
Additional Information:

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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT02969395    
Other Study ID Numbers: 3T
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Keywords provided by Medtronic:
3T
Magnetic Resonance Imaging (MRI)
Implantable Cardioverter Defibrillator (ICD)
Implantable Pulse Generator (IPG)
Cardiac Resynchronization Therapy (CRT)
Cardiac Implantable Electronic Device (CIED)
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes