MRI Clinical Trial
— CDMROfficial title:
University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
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] |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
University Health Care System, Augusta, Georgia |
United States,
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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