Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Magnetic Field Exposure Clinical Trial

— PROMeNADe  

Official title:

Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081364
• Other study ID #: 15-335
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2022

Study information

• Verified date: June 2023
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)

Description:

At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Anyone with a cardiac device

Exclusion Criteria:

• Anyone who cannot consent for themselves or who don't have a durable power of attorney

Related Conditions & MeSH terms

• Magnetic Field Exposure

Intervention

Other:
• Initiate ACLS protocol if lethal arrythmia develops
Cardiac Rhythm Management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saint Luke's Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Device Function	Change in lead impedance or sensing	3 years
Primary	Change in Thresholds of Pacing Lead	Measured in mA	3 years
Primary	Dysrhythmias Noted During Scan	Change in heart rhythm	3 years
Primary	Oxygen Saturation	Percentage of change or no change	3 years
Primary	Change in heart rate	Measured as beats per minute on single-lead heart monitor.	3 years
Primary	Patient Comments	Real-time patient report via intercom during scan of chest symptoms such as burning or aching	3 years
Primary	Interference Between the Implanted Cardiac Electronic Device and MRI	Measure any change in device battery voltage	3 years
Primary	Change in blood pressure	Monitored with automatic blood pressure cuff	3 years