Trial Outcomes & Findings for Mid-Q Response Study (NCT NCT04180696)
NCT ID: NCT04180696
Last Updated: 2025-07-09
Results Overview
The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post-randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened New York Heart Association (NYHA) class (using last observation carried forward), or worsened status on the Global Assessment Score. Also, patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged including all patients that miss NYHA class and Global Assessment Score data and are not classified Worsened because of death, HF hospitalization, exit or crossover.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
177 participants
Primary outcome timeframe
6 months post-randomization
Results posted on
2025-07-09
Participant Flow
The study was multicentric and in a hospital setting, patients selected were heart failure patients in Asian countries indicated for CRT per local guidelines with moderately wide QRS (duration ≥120ms and \<150ms), preserved AV conduction (PR interval ≤ 200 ms), along with a Left bundle branch block (LBBB).
Patients were enrolled as long as they met the inclusion criteria and were willing to consent. A total of 177 subjects were enrolled, of which 171 subjects were randomized between Adaptive and Conventional CRT.
Participant milestones
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
AdaptivCRT programmed to "Adaptive Bi-V and LV". The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
|
Overall Study
COMPLETED
|
80
|
78
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
AdaptivCRT programmed to "Adaptive Bi-V and LV". The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Overall Study
Death
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 Participants
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 Participants
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 11.3 • n=86 Participants
|
65.8 years
STANDARD_DEVIATION 13.7 • n=85 Participants
|
66.4 years
STANDARD_DEVIATION 12.5 • n=171 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=86 Participants
|
25 Participants
n=85 Participants
|
54 Participants
n=171 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=86 Participants
|
60 Participants
n=85 Participants
|
117 Participants
n=171 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
NYHA class
NYHA class I
|
1 Participants
n=86 Participants
|
1 Participants
n=85 Participants
|
2 Participants
n=171 Participants
|
|
NYHA class
NYHA class II
|
30 Participants
n=86 Participants
|
31 Participants
n=85 Participants
|
61 Participants
n=171 Participants
|
|
NYHA class
NYHA class IIII
|
52 Participants
n=86 Participants
|
47 Participants
n=85 Participants
|
99 Participants
n=171 Participants
|
|
NYHA class
NYHA class IV
|
3 Participants
n=86 Participants
|
6 Participants
n=85 Participants
|
9 Participants
n=171 Participants
|
|
LVEF
|
27.0 percent
STANDARD_DEVIATION 6.6 • n=86 Participants
|
25.2 percent
STANDARD_DEVIATION 6.5 • n=85 Participants
|
26.1 percent
STANDARD_DEVIATION 6.6 • n=171 Participants
|
|
QRS duration
|
136.9 ms
STANDARD_DEVIATION 9.4 • n=86 Participants
|
136.1 ms
STANDARD_DEVIATION 9.0 • n=85 Participants
|
136.5 ms
STANDARD_DEVIATION 9.2 • n=171 Participants
|
|
PR interval
|
173.2 ms
STANDARD_DEVIATION 21.0 • n=86 Participants
|
174.3 ms
STANDARD_DEVIATION 21.4 • n=85 Participants
|
173.7 ms
STANDARD_DEVIATION 21.1 • n=171 Participants
|
PRIMARY outcome
Timeframe: 6 months post-randomizationPopulation: All randomized subjects
The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post-randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened New York Heart Association (NYHA) class (using last observation carried forward), or worsened status on the Global Assessment Score. Also, patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged including all patients that miss NYHA class and Global Assessment Score data and are not classified Worsened because of death, HF hospitalization, exit or crossover.
Outcome measures
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 Participants
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 Participants
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Clinical Composite Score
Improved
|
66 Participants
|
68 Participants
|
|
Clinical Composite Score
Unchanged
|
10 Participants
|
11 Participants
|
|
Clinical Composite Score
Worsened
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 and 12 months post-randomizationPopulation: All randomized subjects
NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Outcome measures
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 Participants
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 Participants
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Change in New York Heart Association (NYHA) Class
Baseline · Class I
|
1 Participants
|
1 Participants
|
|
Change in New York Heart Association (NYHA) Class
Baseline · Class II
|
30 Participants
|
31 Participants
|
|
Change in New York Heart Association (NYHA) Class
Baseline · Class III/IV
|
55 Participants
|
53 Participants
|
|
Change in New York Heart Association (NYHA) Class
Baseline · Not reported
|
0 Participants
|
0 Participants
|
|
Change in New York Heart Association (NYHA) Class
3 Month · Class I
|
24 Participants
|
22 Participants
|
|
Change in New York Heart Association (NYHA) Class
3 Month · Class II
|
49 Participants
|
53 Participants
|
|
Change in New York Heart Association (NYHA) Class
3 Month · Class III/IV
|
11 Participants
|
4 Participants
|
|
Change in New York Heart Association (NYHA) Class
3 Month · Not reported
|
2 Participants
|
6 Participants
|
|
Change in New York Heart Association (NYHA) Class
6 Month · Class I
|
23 Participants
|
27 Participants
|
|
Change in New York Heart Association (NYHA) Class
6 Month · Class II
|
50 Participants
|
52 Participants
|
|
Change in New York Heart Association (NYHA) Class
6 Month · Class III/IV
|
11 Participants
|
3 Participants
|
|
Change in New York Heart Association (NYHA) Class
6 Month · Not reported
|
2 Participants
|
3 Participants
|
|
Change in New York Heart Association (NYHA) Class
12 Month · Class I
|
35 Participants
|
32 Participants
|
|
Change in New York Heart Association (NYHA) Class
12 Month · Class II
|
41 Participants
|
42 Participants
|
|
Change in New York Heart Association (NYHA) Class
12 Month · Class III/IV
|
8 Participants
|
9 Participants
|
|
Change in New York Heart Association (NYHA) Class
12 Month · Not reported
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 months post-randomizationPopulation: All randomized subjects
Defined as an event requiring inpatient hospitalization or invasive intervention
Outcome measures
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 Participants
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 Participants
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Occurrence of Hospitalizations for Worsening Heart Failure
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 months post-randomizationPopulation: All randomized subjects
All-cause mortality in the aCRT ON group vs the aCRT OFF group
Outcome measures
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 Participants
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 Participants
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
All-cause Mortality
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 months post-randomizationPopulation: All randomized subjects
Defined as all cardiac deaths as well as any cardiovascular deaths that are not directly a result of mechanical or electrical heart dysfunction.
Outcome measures
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 Participants
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 Participants
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Cardiovascular-related Mortality
|
3 Participants
|
3 Participants
|
Adverse Events
AdaptivCRT ON (aCRT ON, Treatment Group)
Serious events: 27 serious events
Other events: 8 other events
Deaths: 5 deaths
AdaptivCRT OFF (aCRT OFF, Control Group)
Serious events: 24 serious events
Other events: 14 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 participants at risk
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 participants at risk
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
2/86 • Number of events 2 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Cardiac failure
|
8.1%
7/86 • Number of events 7 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
8.2%
7/85 • Number of events 12 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Cardiac failure acute
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Mitral valve incompetence
|
2.3%
2/86 • Number of events 2 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Myocardial injury
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
2.4%
2/85 • Number of events 2 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
General disorders
Death
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
General disorders
Impaired healing
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
General disorders
Implant site haematoma
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
General disorders
Medical device site inflammation
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Hepatobiliary disorders
Congestive hepatopathy
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Appendicitis
|
2.3%
2/86 • Number of events 2 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Bacterial infection
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
2.4%
2/85 • Number of events 2 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Device related infection
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Pleural infection bacterial
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
2.4%
2/85 • Number of events 3 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Pneumonia aspiration
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Post procedural cellulitis
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Sepsis
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Septic shock
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Nervous system disorders
Post stroke epilepsy
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Product Issues
Lead dislodgement
|
3.5%
3/86 • Number of events 3 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Renal and urinary disorders
Urethral perforation
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
Other adverse events
| Measure |
AdaptivCRT ON (aCRT ON, Treatment Group)
n=86 participants at risk
AdaptivCRT programmed to "Adaptive Bi-V and LV The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise.
aCRT ON: CRT device with AdaptivCRT enabled
|
AdaptivCRT OFF (aCRT OFF, Control Group)
n=85 participants at risk
AdaptivCRT programmed to "Nonadaptive CRT" (standard CRT). Control group subjects will be optimized per physician's discretion. The method of AV and VV optimization in the control group will be collected.
aCRT OFF: CRT device with AdaptivCRT disabled
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.5%
3/86 • Number of events 3 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
3.5%
3/85 • Number of events 3 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
General disorders
Implant site pain
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
General disorders
Medical device site pain
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Infections and infestations
Implant site infection
|
1.2%
1/86 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
0.00%
0/85 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Product Issues
Device stimulation issue
|
3.5%
3/86 • Number of events 3 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
8.2%
7/85 • Number of events 8 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/86 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
1.2%
1/85 • Number of events 1 • The data were collected from the time the subject signed informed consent until they completed the study, 12 months post-randomization.
All serious, cardiovascular, device or procedure-related events were considered reportable. Pre-existing conditions that existed prior to study participation were not considered reportable, unless the condition recurred after the patient had recovered from the pre-existing condition, or the condition worsened in intensity or frequency during the study. Planned hospitalizations for a pre-existing condition without serious deterioration in health were not considered SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place