Advisa MRI Clinical Study
Advisa MRI™ System Clinical Investigation
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
This NA trial investigates Cardiac Pacemaker, Artificial and Magnetic Resonance Imaging and is currently completed. Medtronic Cardiac Rhythm and Heart Failure leads this study, which shows 7 recorded versions since 2010 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.
Study Description(click to expand)The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.
The Advisa MRI IPG is a dual chamber, multi-programmable IPG. The IPG is indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
Subjects will have required follow-up visits after implant, at 2 months, 9-12 weeks, 3 months, 4 months, 6 months and every 6 months thereafter until the study ends. The MR scans will occur at the 9-12 weeks visit.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed NA
-
Sep 2024 — Sep 2025 [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Jan 2021 — Jul 2024 [monthly]
Completed NA
-
Jun 2018 — Jan 2021 [monthly]
Completed NA
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed NA
-
Jan 2017 — Feb 2017 [monthly]
Completed NA
First recorded
Jun 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Medtronic Cardiac Rhythm and Heart Failure
For direct contact, visit the study record on ClinicalTrials.gov .