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NCT02969395 · ClinicalTrials.gov registry record
3T MRI CIED Post-Approval Study
A clinical trial, sponsored by Medtronic.
- Completed
- Registry status
- 41
- Enrollment target
NCT02969395 is a clinical trial that has completed, run by Medtronic. The registered enrollment target is 41 participants.
The verdict
NCT02969395 has completed, sponsored by Medtronic.
- COMPLETED
- Registry status
- 41 participants
- Enrollment target
Study 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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2016-04 |
| Est. Completion | 2021-10-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02969395
The ClinicalTrials.gov registry entry for NCT02969395 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02969395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02969395 about?
NCT02969395 is a clinical study titled "3T MRI CIED Post-Approval Study". 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 ...
What is the current status of trial NCT02969395?
This trial is currently completed. The enrollment target is 41 participants. The study started on 2016-04. Estimated completion is 2021-10-15.
Who is sponsoring clinical trial NCT02969395?
This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.
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