Trial Outcomes & Findings for Advisa MRI Clinical Study (NCT NCT01110915)

Last Updated: 2013-04-30

Results Overview

For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.

Recruitment status

COMPLETED

Study phase

Target enrollment

269 participants

Primary outcome timeframe

MRI scan to one-month post-MRI scan

Results posted on

2013-04-30

Participant Flow

Enrollment occurred from June 22, 2010 to October 12, 2011. A total of 269 subjects were enrolled at 35 centers.

A successful implant is defined as having a complete Advisa MRI system implant(Advisa MRI implable pulse generator (IPG) and two Model 5086MRI leads). Six subjects were exited prior to randomization. Of them, 3 subjects did not have an implant attempt and 3 subjects did not have a full Advisa MRI system. All other enrolled subjects were randomized.

Participant milestones

Participant milestones
Measure	MRI Group Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Overall Study STARTED	177	86
Overall Study COMPLETED	167	84
Overall Study NOT COMPLETED	10	2

Reasons for withdrawal

Reasons for withdrawal
Measure	MRI Group Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Overall Study Death	2	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	7	1

Baseline Characteristics

Advisa MRI Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRI Group n=177 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group n=86 Participants Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.	Total n=263 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	24 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	118 Participants n=5 Participants	62 Participants n=7 Participants	180 Participants n=5 Participants
Age Continuous	68.1 years STANDARD_DEVIATION 12.8 • n=5 Participants	68.7 years STANDARD_DEVIATION 10.8 • n=7 Participants	68.3 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	32 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	54 Participants n=7 Participants	163 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	17 participants n=7 Participants	52 participants n=5 Participants
Region of Enrollment Australia	15 participants n=5 Participants	5 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Europe	112 participants n=5 Participants	56 participants n=7 Participants	168 participants n=5 Participants
Region of Enrollment Middle East	10 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: MRI scan to one-month post-MRI scan

Population: Subjects who had an MRI scan and completed their 4-month visit (or a later follow-up), or had an MRI-related complication within one month post-MRI were included in the analysis.

Outcome measures

Outcome measures
Measure	MRI Group n=148 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Magnetic Resonance Imaging (MRI)-Related Complications	0 participants	—

PRIMARY outcome

Timeframe: Pre-MRI/waiting period to one month post-MRI/waiting period

Population: To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.

Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.

Outcome measures

Outcome measures
Measure	MRI Group n=141 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group n=75 Participants Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Atrial Pacing Capture Threshold Success	141 participants	75 participants

PRIMARY outcome

Timeframe: Pre-MRI /waiting period to 1-month post-MRI/waiting period

Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.

Outcome measures

Outcome measures
Measure	MRI Group n=149 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group n=80 Participants Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Ventricular Pacing Capture Threshold Success	146 participants	78 participants

SECONDARY outcome

Timeframe: Pre-MRI /waiting period to 1-month post-MRI/waiting period

Population: Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.

Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.

Outcome measures

Outcome measures
Measure	MRI Group n=138 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group n=73 Participants Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Atrial Sensed Amplitude Success	134 participants	72 participants

SECONDARY outcome

Timeframe: Pre-MRI /waiting period to 1-month post-MRI/waiting period

Population: Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.

Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.

Outcome measures

Outcome measures
Measure	MRI Group n=140 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group n=75 Participants Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Ventricular Sensed Amplitude Success	138 participants	74 participants

SECONDARY outcome

Timeframe: During MRI scans

Population: All subjects successfully implanted with the Advisa MRI system who underwent MRI scans were included in the analysis. All MRI scans, whether done at the 9-12 week visit in the MRI group, or done at other times in either group were included in this analysis.

The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the AEAC.

Outcome measures

Outcome measures
Measure	MRI Group n=156 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.	0 participants	—

SECONDARY outcome

Timeframe: Implant to four months post implant

Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.

Outcome measures

Outcome measures
Measure	MRI Group n=263 Participants Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
System-related Complications	20 participants	—

Adverse Events

MRI Group

Serious events: 45 serious events

Other events: 10 other events

Deaths: 0 deaths

Control Group

Serious events: 21 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	MRI Group n=177 participants at risk Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.	Control Group n=86 participants at risk Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
Cardiac disorders Atrial fibrillation	5.1% 9/177 • Number of events 9 • Up to 19 months. Adverse events were collected from all the subjects enrolled in this study, including 263 randomized and 6 non-randomized subjects. Because there were no adverse events in any of the 6 non-randomized subjects, they are not included in the following summary tables for adverse events.	2.3% 2/86 • Number of events 2 • Up to 19 months. Adverse events were collected from all the subjects enrolled in this study, including 263 randomized and 6 non-randomized subjects. Because there were no adverse events in any of the 6 non-randomized subjects, they are not included in the following summary tables for adverse events.
General disorders Device pacing issue	0.56% 1/177 • Number of events 1 • Up to 19 months. Adverse events were collected from all the subjects enrolled in this study, including 263 randomized and 6 non-randomized subjects. Because there were no adverse events in any of the 6 non-randomized subjects, they are not included in the following summary tables for adverse events.	5.8% 5/86 • Number of events 5 • Up to 19 months. Adverse events were collected from all the subjects enrolled in this study, including 263 randomized and 6 non-randomized subjects. Because there were no adverse events in any of the 6 non-randomized subjects, they are not included in the following summary tables for adverse events.

Additional Information

Advisa MRI Clinical Research Specialist

Medtronic, Inc

Phone: 800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
Publication restrictions are in place

Restriction type: OTHER