NCT02815384

Brief Summary

The research goal is to continue to add to the extensive body of peer-reviewed evidence that demonstrates MRI may be safely performed in patients with cIEDs, after they have been evaluated and cleared by cardiology. This study will allow the researchers to collect data from the facilities ongoing clinical practice regarding the number and types of any adverse clinical reactions, and also to document any changes in the implanted cardiac device that may have occurred during the MRI scan. The researchers will also be assessing the results of the MRI and how the imaging findings impact patient care and the clinical outcome of the patient. This data will then be presented to the FDA and the Centers for Medicare and Medicaid Services to further influence federal guidelines and payment structures.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

September 19, 2024

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

May 26, 2016

Last Update Submit

September 4, 2024

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Safety of MRI, adverse clinical events

    collect safety data

    immediately post MRI

Secondary Outcomes (3)

  • Impact to Patient Care

    6 months

  • Morbidity, Number of hospitalizations

    6 months

  • Mortality, outcome of death

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that require an MRI as part of the normal course of their medical care that also have a cIED and are candidates for MRI .

You may qualify if:

  • All patients that require an MRI as part of the normal course of their medical care that also have a cIED and are candidates for MRI .

You may not qualify if:

  • patient does not require an MRI for their medical care
  • patient does not have a cIED
  • patient has not been seen or approved by cardiology to be a candidate for MRI
  • patients under the age of 18
  • pregnant patients
  • prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner University Medical Center-Tucson

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bobby Kalb, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 28, 2016

Study Start

October 12, 2017

Primary Completion

April 16, 2019

Study Completion

April 16, 2019

Last Updated

September 19, 2024

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)