Trial Outcomes & Findings for SJM MRI Diagnostic Imaging Registry (IDE) (NCT NCT02807948)

NCT ID: NCT02807948

Last Updated: 2019-08-26

Results Overview

Based on the ability of the radiologist to read and provide a diagnosis/report.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 189 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2019-08-26

Participant Flow

Participant milestones

Measure	Pacemaker or CRT-P Device Patients Subjects who need a non-thoracic clinically indicated scan Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose	ICD or CRT-D Device Patients Subjects who need a non-thoracic clinically indicated scan Implantable Cardioverter Defibrillatoror (ICD) or a Cardiac Re-synchronization Therapy -Defibrillator (CRT-D) device: MRI Scans on SJM device implanted subjects for clinical purpose
Overall Study STARTED	132	57
Overall Study COMPLETED	131	57
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Pacemaker or CRT-P Device Patients Subjects who need a non-thoracic clinically indicated scan Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose	ICD or CRT-D Device Patients Subjects who need a non-thoracic clinically indicated scan Implantable Cardioverter Defibrillatoror (ICD) or a Cardiac Re-synchronization Therapy -Defibrillator (CRT-D) device: MRI Scans on SJM device implanted subjects for clinical purpose
Overall Study Physician Decision	1	0

Baseline Characteristics

SJM MRI Diagnostic Imaging Registry (IDE)

Baseline characteristics by cohort

Measure	Pacemaker, ICD, or CRT Device Patients n=189 Participants Subjects who need a non-thoracic clinically indicated scan Pacemaker, ICD, or CRT device: MRI Scans on SJM device implanted subjects for clinical purpose
Age, Continuous	70.7 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	174 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	189 participants n=5 Participants
Arrhythmia History Atrial Arrhythmia	94 Participants n=5 Participants
Arrhythmia History Ventricular Arrhythmia	26 Participants n=5 Participants
Arrhythmia History No Arrhythmia History	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Proportion of MRI scans from CRT-Ps or Pacemakers providing sufficient image quality for diagnostic interpretation

Based on the ability of the radiologist to read and provide a diagnosis/report.

Outcome measures

Measure	Pacemaker or CRT-P Device Patients n=131 MRI Scans Subjects who need a non-thoracic clinically indicated scan Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose
The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.	129 MRI Scans

PRIMARY outcome

Timeframe: 1 month

Population: Proportion of MRI scans from ICDs or CRT-Ds providing sufficient image quality for diagnostic interpretation

Based on the ability of the radiologist to read and provide a diagnosis/report.

Outcome measures

Measure	Pacemaker or CRT-P Device Patients n=57 MRI Scans Subjects who need a non-thoracic clinically indicated scan Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose
The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.	56 MRI Scans

Adverse Events

Pacemaker, ICD, or CRT Device Patients

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pacemaker, ICD, or CRT Device Patients n=189 participants at risk Subjects who need a non-thoracic clinically indicated scan Pacemaker, ICD, or CRT device: MRI Scans on SJM device implanted subjects for clinical purpose
General disorders Chest Pain/ Discomfort	1.1% 2/189 • Number of events 2 • Adverse events were collected from study enrollment until 1 month after the MRI scan was performed. A Clinical Events Committee (CEC) composed of physicians who were not actively involved as investigators in any of the studies under the committee's review, nor may they have any significant financial interest in the technology under study, reviewed and adjudicated all adverse device effects, whether serious or not, and all deaths that were reported during the study.
Cardiac disorders Back-Up Operation	0.53% 1/189 • Number of events 1 • Adverse events were collected from study enrollment until 1 month after the MRI scan was performed. A Clinical Events Committee (CEC) composed of physicians who were not actively involved as investigators in any of the studies under the committee's review, nor may they have any significant financial interest in the technology under study, reviewed and adjudicated all adverse device effects, whether serious or not, and all deaths that were reported during the study.
Infections and infestations Respiratory Infection	0.53% 1/189 • Number of events 1 • Adverse events were collected from study enrollment until 1 month after the MRI scan was performed. A Clinical Events Committee (CEC) composed of physicians who were not actively involved as investigators in any of the studies under the committee's review, nor may they have any significant financial interest in the technology under study, reviewed and adjudicated all adverse device effects, whether serious or not, and all deaths that were reported during the study.

Additional Information

Adam M.Cline, MD, MSc.- Principal Scientist

Abbott

Phone: 818-493-2025

Email: adam.cline@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60