Trial Outcomes & Findings for Registry of Patients for MRI With Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICD (NCT NCT02318550)

NCT ID: NCT02318550

Last Updated: 2021-08-31

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 262 participants
• Primary outcome timeframe: Through procedure completion, an average of 1 hour
• Results posted on: 2021-08-31

Participant Flow

Participant milestones

Measure	Single Arm: Received MRI This group received an MRI and pre- and post-imaging device checks.
Overall Study STARTED	262
Overall Study COMPLETED	262
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Registry of Patients for MRI With Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICD

Baseline characteristics by cohort

Measure	Single Arm: Received MRI n=262 Participants This group received an MRI and pre- and post-imaging device checks.
Age, Customized Number of participants	73.9 years n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants
Sex: Female, Male Male	161 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	10 Participants n=5 Participants
Race (NIH/OMB) White	243 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=262 Participants This group received an MRI and pre- and post-imaging device checks.
Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI	2 Participants

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=262 Participants This group received an MRI and pre- and post-imaging device checks.
Number of Participants With Potentially Lethal/Previously Non-diagnosed Arrhythmias During MRI	0 Participants

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=262 Participants This group received an MRI and pre- and post-imaging device checks.
Number of Participants With Spontaneous and Unanticipated Pacing Rate Change	0 Participants

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=262 Participants This group received an MRI and pre- and post-imaging device checks.
Number of Participants With Power on Reset of Pacemaker or ICD	0 Participants

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=262 Participants This group received an MRI and pre- and post-imaging device checks.
Number of Participants With MRI Related Device Malfunction/Failure	0 Participants

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=262 Participants This group received an MRI and pre- and post-imaging device checks.
Number of Participants With Serious Injury/Death Related to MRI Device Malfunction/Failure	0 Participants

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=318 MRI Scan This group received an MRI and pre- and post-imaging device checks.
Number of MRI Scans With Post-MRI Device Parameter Change: Greater Than 50 Ohm Change in Atrial or Ventricular (RV and/or LV) Lead Impedance	19 MRI Scan

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=318 MRI Scan This group received an MRI and pre- and post-imaging device checks.
Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 5 Ohm Change in High Voltage Lead Impedance	1 MRI Scan

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=318 MRI Scan This group received an MRI and pre- and post-imaging device checks.
Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 50% Decrease in Atrial or Ventricular (RV and/or LV) Sensing Threshold	0 MRI Scan

PRIMARY outcome

Timeframe: Through procedure completion, an average of 1 hour

Outcome measures

Measure	Single Arm: Received MRI n=318 MRI Scan This group received an MRI and pre- and post-imaging device checks.
Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than or Equal to a 1 Volt Increase in Atrial or Ventricular (RV and/or LV) Pacing Threshold	0 MRI Scan

Adverse Events

Single Arm: Received MRI

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Arm: Received MRI n=262 participants at risk This group received an MRI and pre- and post-imaging device checks.
Product Issues Burning/pulling sensation	1.1% 3/262 • Number of events 3 • up to 1 hour following MRI
Cardiac disorders Chest Pain	0.38% 1/262 • Number of events 1 • up to 1 hour following MRI

Additional Information

Project Manager

Lancaster General Health

Phone: 7175447395

Email: Tawnya.Vernon@pennmedicine.upenn.edu

Results disclosure agreements

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