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

MRI Clinical Trial

— CDMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548819
• Other study ID #: IORG0000351
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: May 30, 2017
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University Health Care System, Augusta, Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Defibrillator
• MRI
• Pacemaker

Intervention

Other:
• MRI
MR imaging of patients with implanted cardiac devices

Locations

Country	Name	City	State
United States	University Hospital	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University Health Care System, Augusta, Georgia

Country where clinical trial is conducted

United States, 

Outcome

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