Trial Outcomes & Findings for ENABLE MRI (Magnetic Resonance Imaging) (NCT NCT02652481)
NCT ID: NCT02652481
Last Updated: 2021-01-25
Results Overview
MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
The time between the MR Scan and MRI + 1 Month
Results posted on
2021-01-25
Participant Flow
Participant milestones
| Measure |
ImageReady MR Conditional Defibrillation System Group
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system.
|
|---|---|
|
Phase 1
STARTED
|
239
|
|
Phase 1
COMPLETED
|
141
|
|
Phase 1
NOT COMPLETED
|
98
|
|
Phase 2
STARTED
|
261
|
|
Phase 2
COMPLETED
|
243
|
|
Phase 2
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ENABLE MRI (Magnetic Resonance Imaging)
Baseline characteristics by cohort
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=498 Participants
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
362 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
381 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African heritage
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
302 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
12 Participants
n=5 Participants
|
|
BMI
|
29.0 kg/m^2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: The time between the MR Scan and MRI + 1 MonthPopulation: All implanted subjects that completed any portion of the study required MR scan and did not have a Medically Necessary Scan (MNS) performed prior to the MRI+1 Month Visit were included in the Primary Safety Endpoint analysis set.
MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit
Outcome measures
| Measure |
ImageReady MR Conditional Defibrillation System Group
n=159 Participants
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system
|
|---|---|
|
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications
|
100 percentage of participants
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: The time between the MR Scan and MRI + 1 MonthPopulation: Did not include subjects that had a MNS between implant and the MRI+1Month Visit; Failed to meet Conditions of Use; Experienced lead-related complication; Had an incomplete scan or no scan, died or withdrew consent, missed a visit, missed lead measurements
Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.
Outcome measures
| Measure |
ImageReady MR Conditional Defibrillation System Group
n=146 Participants
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system
|
|---|---|
|
Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV
|
99.32 percentage of participants with success
Interval 96.79 to 100.0
|
PRIMARY outcome
Timeframe: The time between the MR Scan and MRI + 1 MonthPopulation: did not include subjects with a MNS between implant and the MRI + 1 Month Visit;failed to meet labeled MRI Conditions of Use, had lead-related complication;had an incomplete scan or no scan; missing lead measurements; missed a visits, subject died or withdrew consent
Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.
Outcome measures
| Measure |
ImageReady MR Conditional Defibrillation System Group
n=120 Participants
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system
|
|---|---|
|
Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.
|
100 percentage of participants with succes
Interval 97.53 to 100.0
|
PRIMARY outcome
Timeframe: The time between the MR Scan and MRI + 1 MonthPopulation: Did not include subjects that had a MNS between implant and the MRI+1Month Visit; Failed to meet Conditions of Use; Experienced lead-related complication; Had an incomplete scan or no scan, died or withdrew consent, missed a visit, missed lead measurements; had an average pre-scan RV sensed amplitude measurement \< 5.0 mV.
Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value. Subjects who had an average pre-scan RV sensed amplitude measurement \< 5.0 mV were excluded from this analysis.
Outcome measures
| Measure |
ImageReady MR Conditional Defibrillation System Group
n=146 Participants
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system
|
|---|---|
|
Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude
|
99.32 percentage of participants with succes
Interval 96.79 to 100.0
|
PRIMARY outcome
Timeframe: The time between the MR Scan and MRI + 1 MonthPopulation: did not include subjects with a MNS between implant and the MRI + 1 Month Visit;failed to meet labeled MRI Conditions of Use, had lead-related complication;had an incomplete scan or no scan; missing lead measurements; missed a visits, subject died or withdrew consent; Average LV sensed amplitude \<5mV (3 patients)
Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement \< 5.0 mV were excluded from this analysis.
Outcome measures
| Measure |
ImageReady MR Conditional Defibrillation System Group
n=118 Participants
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system
|
|---|---|
|
Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude
|
98.31 percentage of participants with succes
Interval 94.76 to 100.0
|
Adverse Events
ImageReady MR Conditional Defibrillation System Group
Serious events: 139 serious events
Other events: 122 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
ImageReady MR Conditional Defibrillation System Group
n=495 participants at risk
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system
|
|---|---|
|
Product Issues
Unable to capture - LV PG System
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Extracardiac stimulation - LV PG System
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Inappropriate Tachy Therapy - SVT - PG System Therapy
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Pacemaker Mediated Tachycardia - PG System Therapy
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Infections and infestations
Infection (>30 days post-implant) - PG System - Subject related
|
1.2%
6/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - Elevated threshold -RV Lead
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - Multiple signs - RV Lead
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - No reported signs - RV Lead
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - No reported signs - LV Lead
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Post-surgical wound discomfort/bruising/swelling
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Adverse reaction - Respiratory - Procedure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Hematoma - Pocket (<=30 days post-implant)
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Pneumothorax - Procedure
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Pericardial effusion - Procedure
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Venous occlusion - Procedure
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Other - PG system procedure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Dyspnea - Heart failure
|
1.6%
8/495 • Number of events 9 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Hypotension - Heart failure
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
2.2%
11/495 • Number of events 11 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Multiple heart failure symptoms
|
5.7%
28/495 • Number of events 37 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
0.81%
4/495 • Number of events 5 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
1.0%
5/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Nonsustained Ventricular Tachycardia (NSVT)
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
1.0%
5/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Atrial (Type I) Flutter
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Hypotension/Orthostatic Hypotension
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Hypertension/Hypertensive Crisis
|
0.20%
1/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Cardiogenic shock
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Cardiac arrest
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Myocardial infarction
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Coronary Artery Disease
|
1.0%
5/495 • Number of events 5 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Peripheral vascular disease
|
1.2%
6/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Syncope
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Dizziness
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Chest pain - Ischemic
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Chest pain - Other
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Palpitations
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Vascular disorders
Adverse reaction - Hypotension
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Adverse reaction - Anesthesia
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.6%
8/495 • Number of events 15 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Adverse reaction - Medication
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Blood and lymphatic system disorders
Systemic infection
|
2.0%
10/495 • Number of events 11 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Skin and subcutaneous tissue disorders
Physical trauma
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Skin and subcutaneous tissue disorders
Localized Infection
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Nervous system disorders
Neurological
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.6%
13/495 • Number of events 20 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.4%
17/495 • Number of events 19 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Reproductive system and breast disorders
Genitourinary
|
1.0%
5/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Renal and urinary disorders
Renal
|
1.4%
7/495 • Number of events 8 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.8%
9/495 • Number of events 11 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Psychiatric disorders
Psychological
|
0.20%
1/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Endocrine disorders
Endocrine
|
2.0%
10/495 • Number of events 12 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
General disorders
Cancer
|
1.4%
7/495 • Number of events 9 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
General disorders
Multi-system failure
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Unable to capture - RV Lead
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Conductor coil fracture - RA Lead
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Migration - PG System - Subject related
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Myocardial perforation with tamponade
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Chest pain - Heart failure
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Pulmonary edema - Heart failure
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Renal insufficiency/failure - Heart failure
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Dehydration - Heart failure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Gastrointestinal - Heart failure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Vascular disorders
Aortic stenosis
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Mitral regurgitation
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Valvular damage/Valvular insufficiency
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Transient Ischemic Attack (TIA)
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Cerebrovascular Accident (CVA)
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Intracardiac thrombus
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Incessant VT/VT Storm
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Infections and infestations
Fever and/or Virus
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Blood and lymphatic system disorders
Hematological
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.61%
3/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
Other adverse events
| Measure |
ImageReady MR Conditional Defibrillation System Group
n=495 participants at risk
This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the "MRI protection mode". This new MRI scan feature was considered "investigational" , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system
|
|---|---|
|
Product Issues
Unable to capture - LV PG System
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Extracardiac stimulation - LV PG System
|
4.0%
20/495 • Number of events 20 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Inappropriate Tachy Therapy - SVT - PG System Therapy
|
1.2%
6/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Pacemaker Mediated Tachycardia - PG System Therapy
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
1.0%
5/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Infections and infestations
Infection (>30 days post-implant) - PG System - Subject related
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - Elevated threshold -RV Lead
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - Multiple signs - RV Lead
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - No reported signs - RV Lead
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Dislodgment - No reported signs - LV Lead
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Post-surgical wound discomfort/bruising/swelling
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Nonsustained Ventricular Tachycardia (NSVT)
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Adverse reaction - Respiratory - Procedure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
2.2%
11/495 • Number of events 12 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Sinus tachycardia
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Hematoma - Pocket (<=30 days post-implant)
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Pneumothorax - Procedure
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Pericardial effusion - Procedure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Venous occlusion - Procedure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Other - PG system procedure
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Dyspnea - Heart failure
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Hypotension - Heart failure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Multiple heart failure symptoms
|
2.8%
14/495 • Number of events 14 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Atrial (Type I) Flutter
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Hypotension/Orthostatic Hypotension
|
0.81%
4/495 • Number of events 4 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Hypertension/Hypertensive Crisis
|
1.2%
6/495 • Number of events 6 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Coronary Artery Disease
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Peripheral vascular disease
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Syncope
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Dizziness
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Chest pain - Ischemic
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Chest pain - Other
|
1.4%
7/495 • Number of events 7 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Palpitations
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Vascular disorders
Adverse reaction - Hypotension
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Adverse reaction - Anesthesia
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Injury, poisoning and procedural complications
Adverse reaction - Medication
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Blood and lymphatic system disorders
Systemic infection
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Skin and subcutaneous tissue disorders
Physical trauma
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Skin and subcutaneous tissue disorders
Localized Infection
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Nervous system disorders
Neurological
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.61%
3/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Reproductive system and breast disorders
Genitourinary
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Renal and urinary disorders
Renal
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Psychiatric disorders
Psychological
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Endocrine disorders
Endocrine
|
0.40%
2/495 • Number of events 2 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
General disorders
Cancer
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
General disorders
Multi-system failure
|
0.00%
0/495 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Elevated threshold - LV PG System
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Psychiatric disorders
Psychological effect due to device therapy - PG System - Subject related
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
pain at device site
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Conductor coil fracture - RA Lead
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Product Issues
Extracardiac stimulation - RV Lead
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Syncope - Heart failure
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Hypertension - Heart failure
|
0.40%
2/495 • Number of events 3 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Vascular disorders
Distal thromboemboli
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Cardiac disorders
Pericardial effusion - Unrelated (non study) procedure or device
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Blood and lymphatic system disorders
Hematological
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
|
Infections and infestations
HEENT
|
0.20%
1/495 • Number of events 1 • Safety data are presented for subjects as from enrollment until study completion ( 4 May 2018)
Investigators were asked to classify whether an adverse event was considered serious or nonserious,whether it was anticipated or unanticipated; met USADE(Unanticipated Serious Adverse Device Effect); UADE (Unanticipated Adverse Device Effect) definition and whether it was device or procedure related. All reportable events experienced by the study subject after giving informed consent were to be reported. Two patients were enrolled in error and three patients were withdrawn (intent); 495 at risk
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place