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NCT01110915 · ClinicalTrials.gov registry record · NA
Advisa MRI Clinical Study
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 269
- Enrollment target
NCT01110915: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01110915 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 269 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01110915, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 269 participants
- Enrollment target
Study Summary
The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).
Primary Outcome
For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.
Interventions
- DEVICE Medtronic Advisa MRI Implantable Pulse Generator (IPG)
- DEVICE Medtronic CapSureFix MRI™ active fixation MRI lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-03 |
| Phase | NA |
What the finished NCT01110915 record still lists
NCT01110915 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Medtronic Advisa MRI Implantable Pulse Generator (IPG) is the first listed.
NCT01110915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01110915 about?
NCT01110915 is a clinical study titled "Advisa MRI Clinical Study". The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the bod...
What is the current status of trial NCT01110915?
This trial is currently completed. It is a NA study. The enrollment target is 269 participants. The study started on 2010-06. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01110915?
The interventions under investigation include: Medtronic Advisa MRI Implantable Pulse Generator (IPG) (DEVICE), Medtronic CapSureFix MRI™ active fixation MRI lead (DEVICE).
Who is sponsoring clinical trial NCT01110915?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01110915's enrollment target sits among peer trials
269 392nd of 2000 higher than 1,609 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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