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

NCT02548819 | Completed

• 1 other identifier: IORG0000351
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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).

Conditions

MRI; Pacemaker; Defibrillator

Outcome Measures

Primary Outcomes (7)

• Battery voltage

  Change in voltage \> 0.04 V

  Immediate

• Pacing lead impedance

  Change in impedance \> 50 Ohms

  Immediate

• Shock impedance

  Change in impedance \> 3 Ohms

  Immediate

• P wave amplitude

  Decrease in amplitude \> 50%

  Immediate

• R wave amplitude

  Decrease in amplitude \> 25%

  Immediate

• Pacing lead threshold

  Threshold increase \> 0.5 V at a fixed pulse width of 0.4ms

  Immediate

• Adverse event

  An adverse clinical event

  Immediate

Interventions

MRI OTHER

MR imaging of patients with implanted cardiac devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require MR imaging in the presence of a pacemaker or ICD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Care System, Augusta, Georgia: lead

Study Sites (1)

University Hospital

Augusta, Georgia, 30901, United States

Location

Study Officials

• Patrick M Aquilina, MD

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Division of Cardiac Electrophysiology

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 14, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)