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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02548819
Other study ID # IORG0000351
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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