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NCT01999751 · ClinicalTrials.gov registry record
Study to Monitor Patients With Pacemakers or ICDs Who Undergo MRI Scans
A clinical trial of Arrhythmias, Cardiac, sponsored by Essentia Health.
- Completed
- Registry status
- 124
- Enrollment target
- 1
- Study location
NCT01999751: Completed study of Arrhythmias, Cardiac, sponsored by Essentia Health.
NCT01999751 is a study of Arrhythmias, Cardiac that has completed, run by Essentia Health. The registered enrollment target is 124 participants, below the 555-participant average among 17 other Arrhythmias, Cardiac trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999751, a study of Arrhythmias, Cardiac, has completed, sponsored by Essentia Health.
- COMPLETED
- Registry status
- 124 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.
Primary Outcome
Any change greater than 1 V at a pulse width of 0.5 msec in a pacemaker or implantable cardioverter-defibrillator lead at any time within 12 months of the MRI scan
Conditions Studied
Interventions
- DEVICE MRI Scan
Study Locations (1)
Minnesota
- St. Mary's Medical Center - Duluth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-04-11 |
What the finished NCT01999751 record still lists
NCT01999751 is an observational study that tracks outcomes without assigning an intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 555-participant average among 17 other Arrhythmias, Cardiac trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Arrhythmias, Cardiac appearing as the primary indexed condition, and to 1 intervention - of which MRI Scan is the first listed.
NCT01999751 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01999751 about?
NCT01999751 is a clinical study titled "Study to Monitor Patients With Pacemakers or ICDs Who Undergo MRI Scans". This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over ...
What is the current status of trial NCT01999751?
This trial is currently completed. The enrollment target is 124 participants. The study started on 2012-10. Estimated completion is 2018-04-11.
What conditions does trial NCT01999751 study?
This clinical trial studies the following conditions: Arrhythmias, Cardiac.
What interventions are being tested in trial NCT01999751?
The interventions under investigation include: MRI Scan (DEVICE).
Who is sponsoring clinical trial NCT01999751?
This trial is sponsored by Essentia Health, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01999751 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01999751's enrollment target sits among peer trials
124 9th of 17 higher than 9 of 17 other Arrhythmias, Cardiac trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arrhythmias, Cardiac 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.
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