Trial Outcomes & Findings for China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD] (NCT NCT03828357)
NCT ID: NCT03828357
Last Updated: 2023-12-07
Results Overview
Freedom from Magnetic Resonance Imaging (MRI) scan related complications related to the Implantable Cardiac Difibrillator (ICD) device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing.
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
1 month from MRI scan
Results posted on
2023-12-07
Participant Flow
Participant milestones
| Measure |
Ellipse VR With Durata
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]
Baseline characteristics by cohort
| Measure |
Ellipse VR With Durata
n=15 Participants
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=15 Participants
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=15 Participants
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=15 Participants
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 14 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Cardiovascular History- dominant type of cardiomyopathy
Non-ischemic
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Cardiovascular History- dominant type of cardiomyopathy
Ischemic
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Cardiovascular History- dominant type of cardiomyopathy
None
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Prior Cardiac Interventions
PTCA/ Stents/ Atherectomy
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Prior Cardiac Interventions
Ablation
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Prior Cardiac Interventions
none
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Arrhythmia History
Ventricular
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Arrhythmia History
Non-ventricular
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Arrhythmia History
Other or not recorded
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Cardiac Arrest
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Ventricular Tachycardia
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Ischemic Cardiomyopathy
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Non-ischemic Cardiomyopathy
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Familial Condition
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Syncope
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
HF with wide QRS
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Primary Indication for ICD/CRT Implant
Reduced EF with frequent dependence on V-pacing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
History of Smoking
Yes
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
History of Smoking
No
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 month from MRI scanPopulation: The primary safety endpoint analysis is conducted on subjects in the Analysis Cohort who completed the 1-month post-MRI scan visit or have MRI-scan related complication(s) related to the ICD/CRT-D device and/or leads.
Freedom from Magnetic Resonance Imaging (MRI) scan related complications related to the Implantable Cardiac Difibrillator (ICD) device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing.
Outcome measures
| Measure |
Ellipse VR With Durata
n=14 Participants
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=14 Participants
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=15 Participants
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=12 Participants
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications
|
14 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: pre-MRI scan to 1 month post-MRI scanPopulation: The primary analysis for the primary effectiveness endpoint #1 is conducted on subjects in the Analysis Cohort who have completed the 1-month post-MRI scan visit, with evaluable device data available for analysis and meet all the following criteria: 1. Have pre-MRI scan visit data for capture threshold 2. Have 1-month post-MRI scan visit data for capture threshold 3. Have not undergone any lead repositioning or replacement since the MRI scan up to 1-month post-MRI scan.
Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1-month post-MRI scan testing.
Outcome measures
| Measure |
Ellipse VR With Durata
n=14 leads
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=28 leads
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=28 leads
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=36 leads
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Effectiveness Outcomes: Percentage of Leads With a Capture Threshold Increase
Right Atrial (RA) leads
|
NA percentage of leads meeting criteria
no RA leads in this group
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
|
Effectiveness Outcomes: Percentage of Leads With a Capture Threshold Increase
Right Ventricular (RV) leads
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
|
Effectiveness Outcomes: Percentage of Leads With a Capture Threshold Increase
Left Ventricular (LV) leads
|
NA percentage of leads meeting criteria
no LV leads in this group
|
NA percentage of leads meeting criteria
no LV leads in this group
|
NA percentage of leads meeting criteria
no LV leads in this group
|
100 percentage of leads meeting criteria
|
PRIMARY outcome
Timeframe: pre-MRI scan to 1 month post-MRI scanPopulation: The primary analysis for the primary effectiveness endpoint #2 is conducted on subjects in the Analysis Cohort who undergo the 1-month post-MRI scan testing, with evaluable device data available for analysis to be performed, and meet all the following criteria: 1. Have pre-MRI scan visit data for sensing amplitude 2. Have 1-month post-MRI scan visit data for sensing amplitude 3. Have not undergone any ICD/CRT-D lead repositioning or replacement since the MRI scan up to 1-month post-MRI scan.
Proportion of subjects with a sensing amplitude decrease ≤ 50% from pre-MRI scan to 1-month post MRI scan % (n/N)
Outcome measures
| Measure |
Ellipse VR With Durata
n=14 leads
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=28 leads
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=28 leads
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=36 leads
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
The Percentage of Leads With a Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1-month Post-MRI Scan.
Right Ventricular Leads
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
|
The Percentage of Leads With a Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1-month Post-MRI Scan.
Right Atrial Leads
|
NA percentage of leads meeting criteria
no Right Atrial Leads in this group
|
100 percentage of leads meeting criteria
|
100 percentage of leads meeting criteria
|
92 percentage of leads meeting criteria
|
SECONDARY outcome
Timeframe: Pre-MRI scan, Post MRI scan, 1 month follow-upPopulation: patients that had respective electrical measurements captured at pre-MRI, post-MRI or 1-month follow-up
Summaries of electrical measurements taken in the Analysis Cohort at Pre-MRI scan, Post-MRI scan, and 1-month post MRI scan. The stable electrical measurements from pre-MRI scan to post-MRI scan and 1-month post MRI scan indicate that the MRI scan did not impact the electrical performance of the Ellipse ICD or Quadra Assura CRT-D system
Outcome measures
| Measure |
Ellipse VR With Durata
n=15 Participants
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=14 Participants
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=15 Participants
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=14 Participants
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Device Electrical Measurements
pre-MRI: Right ventricular capture threshold
|
0.72 Volts
Standard Deviation 0.19
|
0.75 Volts
Standard Deviation 0.24
|
0.80 Volts
Standard Deviation 0.19
|
0.7 Volts
Standard Deviation 0.22
|
|
Device Electrical Measurements
pre-MRI: Right ventricular sensing amplitude
|
0.0113 Volts
Standard Deviation 0.0015
|
0.0110 Volts
Standard Deviation 0.0021
|
0.0108 Volts
Standard Deviation 0.0019
|
0.0119 Volts
Standard Deviation 0.2
|
|
Device Electrical Measurements
post-MRI: Right ventricular capture threshold
|
0.71 Volts
Standard Deviation 0.19
|
0.75 Volts
Standard Deviation 0.20
|
0.73 Volts
Standard Deviation 0.18
|
0.63 Volts
Standard Deviation 0.17
|
|
Device Electrical Measurements
post-MRI: Right ventricular sensing amplitude
|
0.0112 Volts
Standard Deviation 0.0017
|
0.0113 Volts
Standard Deviation 0.0022
|
0.0108 Volts
Standard Deviation 0.0017
|
0.0117 Volts
Standard Deviation 0.0008
|
|
Device Electrical Measurements
1 month follow-up: Right ventricular capture threshold
|
0.73 Volts
Standard Deviation 0.18
|
0.73 Volts
Standard Deviation 0.18
|
0.80 Volts
Standard Deviation 0.2
|
0.63 Volts
Standard Deviation 0.2
|
|
Device Electrical Measurements
1 month follow-up: Right ventricular sensing amplitude
|
0.0114 Volts
Standard Deviation 0.0014
|
0.0109 Volts
Standard Deviation 0.0026
|
0.0112 Volts
Standard Deviation 0.0013
|
0.0117 Volts
Standard Deviation 0.0007
|
SECONDARY outcome
Timeframe: during MRI scanPopulation: Subjects that completed study MRI scan were included in analysis
Whole body (WB) SAR values from the RF intensive MRI scans. Abbott is seeking MR-conditional labeling for MRI scans in Normal Operating Mode (WB Specific Absorption Rate (SAR) up to 2 W/kg). Achieving a WB SAR of exactly 2 W/kg is not feasible since the MR technologist must adjust multiple interdependent scab parameters to increase the WB SAR. Therefore, an acceptable limit of ≥ 1.8 W/kg (within 10%) was established as part of the MRI scan sequence guideline document for this study prior to site enrollments to account for expected user variability.
Outcome measures
| Measure |
Ellipse VR With Durata
n=14 Participants
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=14 Participants
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=15 Participants
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=12 Participants
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Number of Participants With Whole Body (WB) SAR Values Measured ≥ 1.8 W/kg
|
14 Participants
|
13 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: MRI scan visitPopulation: Subjects that completed MRI scan were included in this analysis
Subjects that returned to usual programming after the MRI scan and the number of subjects experiencing delays in disabling MRI settings after the MRI scan
Outcome measures
| Measure |
Ellipse VR With Durata
n=14 Participants
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=14 Participants
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=15 Participants
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=12 Participants
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Summary of Subjects That Returned to Usual Programming
Number of subjects with a delay in disabling MRI settings after MRI scan
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Subjects That Returned to Usual Programming
Number of subjects that returned to usual programming after the MRI scan
|
14 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
Adverse Events
Ellipse VR With Durata
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Ellipse DR With Durata & Tendril STS
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Ellipse DR With Optisure and Isoflex
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Quadra Assura MP CRT-D
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ellipse VR With Durata
n=14 participants at risk
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=14 participants at risk
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=15 participants at risk
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=12 participants at risk
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
OTHER: CERVICAL SPONDYLOSIS
|
7.1%
1/14 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/15 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/12 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
|
Cardiac disorders
OTHER:HEART FAILURE
|
7.1%
1/14 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
7.1%
1/14 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/15 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/12 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
|
Respiratory, thoracic and mediastinal disorders
OTHER:Chronic obstructive pulmonary disease
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
7.1%
1/14 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/15 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/12 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
|
Cardiac disorders
OTHER: CAROTID SCLEROSIS
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
6.7%
1/15 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/12 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
|
Renal and urinary disorders
OTHER: HYPERKALEMIA
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
6.7%
1/15 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/12 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
|
Cardiac disorders
OTHER: DILATED CARDIOMYOPATHY
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/15 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
8.3%
1/12 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
|
Product Issues
OTHER:INAPPROPIATE SHOCK
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
7.1%
1/14 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/15 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/12 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
Other adverse events
| Measure |
Ellipse VR With Durata
n=14 participants at risk
Ellipse VR single-chamber ICD with a Durata defibrillation lead
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Durata & Tendril STS
n=14 participants at risk
Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Ellipse DR With Optisure and Isoflex
n=15 participants at risk
Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
Quadra Assura MP CRT-D
n=12 participants at risk
Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
Study MRI scan: At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
|
|---|---|---|---|---|
|
Cardiac disorders
OTHER: VENTRICULAR FIBRILLATION
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/14 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
6.7%
1/15 • Number of events 1 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
0.00%
0/12 • from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60