University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02548819

Acronym

CDMR

Enrollment

220

Registered

2015-09-14

Start date

2015-09-30

Completion date

2017-03-31

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defibrillator, MRI, Pacemaker

Brief summary

A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

Detailed description

Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.

Interventions

OTHERMRI

MR imaging of patients with implanted cardiac devices

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Male or female 18 years or older * Informed consent can be provided by patient or medical power of attorney * Presence of implanted pacemaker or ICD * MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician * Non-cardiac/non-thoracic MRI ordered

Exclusion criteria

* Presence of metallic objects that represent a contraindication to MR imaging * Morbid obesity which results in body contact with the magnet façade * Pacemaker or ICD generator implanted prior to 2002 * ICD patients who are pacing dependent * Pregnancy * Device generator at ERI (elective replacement interval) * Presence of other active implanted medical device * Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires) * Presence of implanted cardiac device in the abdominal position * Pacemaker or ICD that is labeled as MRI-Conditional by the FDA * Pacemaker or ICD implanted less than 6 weeks prior to MRI scan

Design outcomes

Primary

Measure	Time frame	Description
Battery voltage	Immediate	Change in voltage \> 0.04 V
Pacing lead impedance	Immediate	Change in impedance \> 50 Ohms
Shock impedance	Immediate	Change in impedance \> 3 Ohms
P wave amplitude	Immediate	Decrease in amplitude \> 50%
R wave amplitude	Immediate	Decrease in amplitude \> 25%
Pacing lead threshold	Immediate	Threshold increase \> 0.5 V at a fixed pulse width of 0.4ms
Adverse event	Immediate	An adverse clinical event

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026