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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 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.

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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.

Conditions Studied

Arrhythmias, Cardiac

Interventions

  • DEVICE MRI Scan

Study Locations (1)

Minnesota

  • St. Mary's Medical Center - Duluth

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2012-10
Est. Completion 2018-04-11

Sponsor

Essentia Health

17 total trials

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What the Registry Record Tells You About NCT01999751

The ClinicalTrials.gov registry entry for NCT01999751 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 555-participant average among 17 other Arrhythmias, Cardiac trials with a reported enrollment target (78% lower). The listed sponsor is Essentia Health, which has 17 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.