NCT02906189

Brief Summary

The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

September 3, 2016

Last Update Submit

September 14, 2016

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Death during the MRI scan

    Immediate

Secondary Outcomes (11)

  • Decrease in battery voltage >0.04v

    6 months

  • Change in pacing lead impedance ≥ 50 Ω

    6 months

  • Change in high-voltage lead impedance ≥ 3 Ω

    6 months

  • Increase in pacing threshold ≥ 0.50 V @ 0.4 ms

    6 months

  • Decrease in P wave measurement ≥ 50%

    6 months

  • +6 more secondary outcomes

Interventions

MRIRADIATION

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-MRI conditional pacemakers and ICDs referred for clinically indicated MRI scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Morris, MD

    Banner University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Morris, MD

CONTACT

602-839-4850michael.morris@bannerhealth.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 3, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)