Trial Outcomes & Findings for Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access (NCT NCT02117414)
NCT ID: NCT02117414
Last Updated: 2016-11-28
Results Overview
Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
275 participants
Primary outcome timeframe
MRI procedure to 1-month post-MRI
Results posted on
2016-11-28
Participant Flow
A total of 275 subjects were enrolled (consented) at 42 centers in the Evera MRI study. The first enrollment occurred on April 17, 2014, and the last enrollment occurred on September 11, 2014.
A successful implant was defined as having received a complete Evera MRI™ Study System (Evera MRI™ DR or VR ICD, one Model 6935M or 6947M lead, and one Model 5076 lead (if DR system)). Eleven subjects did not have an implant attempt and one subject did not have a successful implant. None of these subjects were randomized.
Participant milestones
| Measure |
MRI Group
Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans
|
Control Group
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
88
|
|
Overall Study
COMPLETED
|
160
|
82
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
MRI Group
Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans
|
Control Group
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Overall Study
Death
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
Baseline Characteristics
Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
Baseline characteristics by cohort
| Measure |
MRI Group
n=175 Participants
Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans
|
Control Group
n=88 Participants
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MRI procedure to 1-month post-MRIPopulation: A total of 156 subjects underwent an MRI scan at the MRI/waiting period visit; of them 147 were followed through the one month post-MRI visit or later and are included in the analysis.
Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.
Outcome measures
| Measure |
MRI Group
n=147 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
MRI-related Events
|
147 Participants free of MRI-related events
|
—
|
PRIMARY outcome
Timeframe: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visitPopulation: 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 MRI/waiting period visit, and all the subjects must have valid VPCT measurements pre-MRI/waiting period and post-MRI/waiting period.
Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.
Outcome measures
| Measure |
MRI Group
n=154 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
n=81 Participants
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Ventricular Pacing Capture Threshold (VPCT)
|
154 Successful participants
|
80 Successful participants
|
PRIMARY outcome
Timeframe: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visitPopulation: Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.
Number of successful patients who do not experience a decrease in ventricular sensing amplitude of \>50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value \<3mV accompanied by a decrease of \>25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.
Outcome measures
| Measure |
MRI Group
n=153 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
n=82 Participants
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Ventricular Sensing Amplitude (R-wave)
|
152 Successful participants
|
81 Successful participants
|
SECONDARY outcome
Timeframe: Implant to 4 months post-implantPopulation: All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.
Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.
Outcome measures
| Measure |
MRI Group
n=264 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
System-related Complications
|
254 Successful participants
|
—
|
SECONDARY outcome
Timeframe: 1-month post-MRI/Waiting Period visitPopulation: Only randomized subjects with measured RV defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an RV defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.
Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Outcome measures
| Measure |
MRI Group
n=145 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
n=81 Participants
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
RV Defibrillation Impedance
|
145 Successful participants
|
80 Successful participants
|
SECONDARY outcome
Timeframe: 1-month post-MRI/Waiting Period visitPopulation: Only randomized subjects with measured SVC defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.
Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms
Outcome measures
| Measure |
MRI Group
n=42 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
n=25 Participants
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Superior Vena Cava (SVC) Defibrillation Impedance
|
42 Successful participants
|
25 Successful participants
|
SECONDARY outcome
Timeframe: Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visitPopulation: 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 MRI/waiting period visit, and all the subjects must have valid APCT measurements pre-MRI/waiting period and post-MRI/waiting period.
Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.
Outcome measures
| Measure |
MRI Group
n=75 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
n=32 Participants
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Atrial Pacing Capture Threshold (APCT)
|
74 Successful participants
|
32 Successful participants
|
SECONDARY outcome
Timeframe: MRI/waiting visit to 1-month post-MRI/Waiting visitPopulation: Only subjects with measured atrial sensing amplitude values at both the pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.
Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.
Outcome measures
| Measure |
MRI Group
n=76 Participants
All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
|
Control Group
n=34 Participants
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Atrial Sensing Amplitude
|
74 Successful participants
|
33 Successful participants
|
Adverse Events
MRI Group
Serious events: 35 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MRI Group
n=175 participants at risk
Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).
MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans
|
Control Group
n=88 participants at risk
Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).
Waiting Period Visit: Waiting period time will equate to 1 hour
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Angina pectoris
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Angina unstable
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Atrial flutter
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Cardiac arrest
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Cardiac failure
|
2.9%
5/175 • Number of events 5 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
5.7%
5/88 • Number of events 6 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Cardiac perforation
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Cardiac tamponade
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Pericardial effusion
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Pericarditis
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.7%
3/175 • Number of events 3 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
2.3%
2/88 • Number of events 2 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 2 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Nausea
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 2 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
General disorders
Chest discomfort
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
General disorders
Chest pain
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
3.4%
3/88 • Number of events 4 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
General disorders
Death
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
General disorders
Implant site haematoma
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
General disorders
Implant site pain
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
General disorders
Lead dislodgement
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Cellulitis
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Encephalitis
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Implant site infection
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Pneumonia
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
2.3%
2/88 • Number of events 2 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Septic shock
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Urinary tract infection
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Infections and infestations
Wound infection
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Renal and urinary disorders
Renal failure
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
2/175 • Number of events 4 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Vascular disorders
Hypotension
|
0.00%
0/175 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
1.1%
1/88 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
|
Vascular disorders
Venous occlusion
|
0.57%
1/175 • Number of events 1 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
0.00%
0/88 • The 263 randomized subjects averaged 4.5 months of implanted follow-up for a total of 97.6 years of follow-up.
There were 158 adverse events in randomized subjects.
|
Other adverse events
Adverse event data not reported
Additional Information
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