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

• Sponsor: University Health Care System, Augusta, Georgia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02548819
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 12.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
MRI; Pacemaker; Defibrillator	Other: MRI

Detailed Description

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

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 220 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Outcome Measures

Primary Outcome Measures

1. Battery voltage [Immediate]

   Change in voltage > 0.04 V

2. Pacing lead impedance [Immediate]

   Change in impedance > 50 Ohms

3. Shock impedance [Immediate]

   Change in impedance > 3 Ohms

4. P wave amplitude [Immediate]

   Decrease in amplitude > 50%

5. R wave amplitude [Immediate]

   Decrease in amplitude > 25%

6. Pacing lead threshold [Immediate]

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

7. Adverse event [Immediate]

   An adverse clinical event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Augusta	Georgia	United States	30901

Sponsors and Collaborators

• University Health Care System, Augusta, Georgia

Investigators

• Principal Investigator: Patrick M Aquilina, MD, University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patrick Aquilina, Physician, Division of Cardiac Electrophysiology, University Health Care System, Augusta, Georgia
• ClinicalTrials.gov Identifier: NCT02548819
• Other Study ID Numbers: IORG0000351
• First Posted: Sep 14, 2015
• Last Update Posted: Jun 1, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Jun 1, 2017