Trial Outcomes & Findings for Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices (NCT NCT01130896)

Results Overview

Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline

Recruitment status

COMPLETED

Target enrollment

1509 participants

Primary outcome timeframe

immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)

Results posted on

2021-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	MRI and Cardiac Devices Clinically indicated MRI (all types) in patients with implanted pacemakers and implantable cardioverter-defibrillator (ICD)
Overall Study STARTED	1509
Overall Study COMPLETED	1509
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRI and Cardiac Devices n=1509 Participants Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Age, Continuous	69.3 years n=99 Participants
Sex: Female, Male Female	548 Participants n=99 Participants
Sex: Female, Male Male	961 Participants n=99 Participants
Region of Enrollment United States	1509 participants n=99 Participants

PRIMARY outcome

Timeframe: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)

Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline

Outcome measures

Outcome measures
Measure	MRI and Cardiac Devices n=1509 Participants Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Device Malfunction immediately post MRI (up to 2 hours)	24 Participants
Device Malfunction Long-term follow-up (up to 6 months)	52 Participants

PRIMARY outcome

Timeframe: assessed during MRI and immediate post MRI (up to 2 hours)

Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)

Outcome measures

Outcome measures
Measure	MRI and Cardiac Devices n=1509 Participants Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Patient Safety	0 Participants

SECONDARY outcome

Timeframe: Immediately post MRI (up to 2 hours)

We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images

Outcome measures

Outcome measures
Measure	MRI and Cardiac Devices n=1509 Participants Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance	0 Participants

Adverse Events

MRI and Cardiac Devices

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRI and Cardiac Devices n=1509 participants at risk Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
Surgical and medical procedures Power on reset	0.53% 8/1509 • Number of events 9

Additional Information

Henry Halperin, MD

Johns Hopkins University

Phone: 410-955-2412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place