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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

Tracking Information
First Submitted Date November 10, 2016
First Posted Date November 21, 2016
Last Update Posted Date July 19, 2021
Study Start Date April 2016
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2019)
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. ]
Original Primary Outcome Measures
 (submitted: November 17, 2016)
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 3 years. ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 3T MRI CIED Post-Approval Study
Official Title Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices
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).
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
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.
Condition Cardiac Rhythm Disorder
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 3, 2019)
4500
Original Estimated Enrollment
 (submitted: November 17, 2016)
2382
Estimated Study Completion Date October 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Medtronic Product Surveillance Registry rs.productsurveillanceregistry@medtronic.com
Listed Location Countries Belgium,   Canada,   China,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Slovenia,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02969395
Other Study ID Numbers 3T
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic
Study Sponsor Medtronic
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic
Verification Date July 2021