Trial Outcomes & Findings for Ingenio Device Algorithm Study (NCT NCT01441583)
NCT ID: NCT01441583
Last Updated: 2024-03-21
Results Overview
Accuracy was evaluated by the proportion of tests resulting in an RAAT commanded threshold with \|Manual unipolar threshold - commanded threshold\| ≤ 0.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted of the manual unipolar threshold and the commanded threshold obtained at a visit.
COMPLETED
NA
139 participants
3 months post implant
2024-03-21
Participant Flow
Subjects were recruited from the general patient population indicated for a dual chamber pacemaker or cardiac resynchronization therapy pacemaker implantation at 15 study centers. First enrollment date was in October 2011 and the last subject was enrolled in March 2012.
Of 139 subjects, 132 were implanted with a study device. Of those subjects who were not implanted with a study device 4 signed informed consent, met eligibility criteria and had anesthesia administered in preparation for the surgical procedure but did not receive a study device (classified as 'Attempt') and 3 signed the informed consent, met eligibility criteria but did not undergo an implant (classified as an 'Intent').
Participant milestones
| Measure |
RYTHMIQ Off at Pre-discharge, On at 1-Month
Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month
|
RYTHMIQ On at Pre-Discharge, Off at 1-Month
Pacemaker -RYTHMIQ On at Pre-Discharge, Off at 1-Month
|
CRT-P
All CRT-P implanted subjects
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
36
|
|
Overall Study
COMPLETED
|
48
|
49
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
9
|
Reasons for withdrawal
| Measure |
RYTHMIQ Off at Pre-discharge, On at 1-Month
Pacemaker - RYTHMIQ Off at Pre-discharge, On at 1-Month
|
RYTHMIQ On at Pre-Discharge, Off at 1-Month
Pacemaker -RYTHMIQ On at Pre-Discharge, Off at 1-Month
|
CRT-P
All CRT-P implanted subjects
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
4
|
|
Overall Study
Underwent anaesthesia, but not finally implanted
|
0
|
0
|
4
|
Baseline Characteristics
Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
Baseline characteristics by cohort
| Measure |
Pacemaker
n=100 Participants
Subjects receiving a pacemaker study device (implanted or attempted)
|
CRT-P
n=36 Participants
Subjects receiving a CRT-P study device (implanted or attempted)
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 10.9 • n=100 Participants
|
72.7 years
STANDARD_DEVIATION 9.5 • n=36 Participants
|
73.2 years
STANDARD_DEVIATION 10.5 • n=136 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=100 Participants
|
28 Participants
n=36 Participants
|
88 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=100 Participants
|
8 Participants
n=36 Participants
|
48 Participants
n=136 Participants
|
|
Pacemaker Indication
AV Block
|
56 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
0 Participants
Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
56 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
|
Pacemaker Indication
Sinus Node Dysfunction
|
37 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
0 Participants
Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
37 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
|
Pacemaker Indication
Other Block (i.e. Chronic Bifascicular Block)
|
5 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
0 Participants
Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
5 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
|
Pacemaker Indication
Hypersensitive Carotid Sinus Syndrome
|
1 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
0 Participants
Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
1 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
|
Pacemaker Indication
Brady-Tachy Syndrome
|
1 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
0 Participants
Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
1 Participants
n=100 Participants • Pacemaker indications are not applicable for CRT-P device category, hence it was not analyzed.
|
|
CRT-P Indication
Class I - EF ≤ 35%, sinus rhythm, NYHA Class III, or ambulatory NYHA Class IV, QRS ≥ 120 ms, OPT
|
0 Participants
CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
19 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
19 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
|
CRT-P Indication
Class IIa - EF ≤ 35%, NYHA Class III, or ambul. NYHA Class IV, OPT, freq. dependence on vent. pacing
|
0 Participants
CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
4 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
4 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
|
CRT-P Indication
Class IIb - EF ≤ 35%, NYHA Class I or II, OPT, device implant with anticipated frequent vent. pacing
|
0 Participants
CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
5 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
5 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
|
CRT-P Indication
Replacement CRT-P device
|
0 Participants
CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
6 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
6 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
|
CRT-P Indication
Other
|
0 Participants
CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
2 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
2 Participants
n=36 Participants • CRT-P indications are not applicable for pacemaker device category, hence it was not analyzed.
|
|
NYHA Class
I
|
24 Participants
n=100 Participants
|
1 Participants
n=36 Participants
|
25 Participants
n=136 Participants
|
|
NYHA Class
II
|
10 Participants
n=100 Participants
|
8 Participants
n=36 Participants
|
18 Participants
n=136 Participants
|
|
NYHA Class
III
|
2 Participants
n=100 Participants
|
21 Participants
n=36 Participants
|
23 Participants
n=136 Participants
|
|
NYHA Class
IV
|
0 Participants
n=100 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=136 Participants
|
|
NYHA Class
Not reported
|
64 Participants
n=100 Participants
|
3 Participants
n=36 Participants
|
67 Participants
n=136 Participants
|
|
LVEF
|
55.7 percent
STANDARD_DEVIATION 10.5 • n=43 Participants • Measure not reported for all subjects.
|
29.2 percent
STANDARD_DEVIATION 8.4 • n=33 Participants • Measure not reported for all subjects.
|
44.1 percent
STANDARD_DEVIATION 16.3 • n=76 Participants • Measure not reported for all subjects.
|
|
QRS Duration
|
109 ms
STANDARD_DEVIATION 33 • n=82 Participants • Measure not reported for all subjects.
|
158 ms
STANDARD_DEVIATION 24 • n=32 Participants • Measure not reported for all subjects.
|
123 ms
STANDARD_DEVIATION 38 • n=114 Participants • Measure not reported for all subjects.
|
|
BMI
|
26.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=87 Participants • Measure not reported for all subjects.
|
27.2 kg/m^2
STANDARD_DEVIATION 4.0 • n=33 Participants • Measure not reported for all subjects.
|
26.6 kg/m^2
STANDARD_DEVIATION 4.1 • n=120 Participants • Measure not reported for all subjects.
|
|
Body Surface Area
|
1.9 m^2
STANDARD_DEVIATION 0.3 • n=87 Participants • Measure not reported for all subjects.
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=33 Participants • Measure not reported for all subjects.
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=120 Participants • Measure not reported for all subjects.
|
|
Concomitant Medications
ACE Inhibitor
|
27 Participants
n=100 Participants
|
18 Participants
n=36 Participants
|
45 Participants
n=136 Participants
|
|
Concomitant Medications
Angiotensin Receptor Blocker
|
26 Participants
n=100 Participants
|
16 Participants
n=36 Participants
|
42 Participants
n=136 Participants
|
|
Concomitant Medications
Diuretics
|
26 Participants
n=100 Participants
|
27 Participants
n=36 Participants
|
53 Participants
n=136 Participants
|
|
Concomitant Medications
Sodium Channel Blockers - Class I
|
3 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=136 Participants
|
|
Concomitant Medications
Beta Blockers - Class II
|
26 Participants
n=100 Participants
|
26 Participants
n=36 Participants
|
52 Participants
n=136 Participants
|
|
Concomitant Medications
Potassium Channel Blockers - Class III
|
4 Participants
n=100 Participants
|
3 Participants
n=36 Participants
|
7 Participants
n=136 Participants
|
|
Concomitant Medications
Calcium Channel Blockers - Class IV
|
26 Participants
n=100 Participants
|
4 Participants
n=36 Participants
|
30 Participants
n=136 Participants
|
|
Concomitant Medications
Other Cardiovascular Medications
|
60 Participants
n=100 Participants
|
29 Participants
n=36 Participants
|
89 Participants
n=136 Participants
|
|
Etiology
No Disease (age related)
|
80 Participants
n=100 Participants
|
4 Participants
n=36 Participants
|
84 Participants
n=136 Participants
|
|
Etiology
Ischemic Cardiomyopathy
|
10 Participants
n=100 Participants
|
17 Participants
n=36 Participants
|
27 Participants
n=136 Participants
|
|
Etiology
Idiopathic Cardiomyopathy
|
3 Participants
n=100 Participants
|
12 Participants
n=36 Participants
|
15 Participants
n=136 Participants
|
|
Etiology
Valvular Cardiomyopathy
|
4 Participants
n=100 Participants
|
3 Participants
n=36 Participants
|
7 Participants
n=136 Participants
|
|
Etiology
Congenital Heart Disease
|
2 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=136 Participants
|
|
Etiology
Hypertrophic Cardiomyopathy
|
1 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=136 Participants
|
|
Atrial Arrhythmias
Paroxysmal Atrial Fibrillation
|
18 Participants
n=100 Participants
|
8 Participants
n=36 Participants
|
26 Participants
n=136 Participants
|
|
Atrial Arrhythmias
Atrial Tachycardia/Flutter
|
7 Participants
n=100 Participants
|
3 Participants
n=36 Participants
|
10 Participants
n=136 Participants
|
|
Atrial Arrhythmias
Persistent Atrial Fibrillation
|
1 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=136 Participants
|
|
Atrial Arrhythmias
Other Supraventricular Tachycardia
|
3 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=136 Participants
|
|
Atrial Arrhythmias
None
|
72 Participants
n=100 Participants
|
26 Participants
n=36 Participants
|
98 Participants
n=136 Participants
|
|
Brady Arrhythmias:
Sinus Node Dysfunction
|
32 Participants
n=100 Participants
|
1 Participants
n=36 Participants
|
33 Participants
n=136 Participants
|
|
Brady Arrhythmias:
3rd Degree AV Block - Intermittent
|
21 Participants
n=100 Participants
|
3 Participants
n=36 Participants
|
24 Participants
n=136 Participants
|
|
Brady Arrhythmias:
2nd Degree AV Block - Intermittent
|
17 Participants
n=100 Participants
|
2 Participants
n=36 Participants
|
19 Participants
n=136 Participants
|
|
Brady Arrhythmias:
3rd Degree AV Block - Permanent
|
15 Participants
n=100 Participants
|
4 Participants
n=36 Participants
|
19 Participants
n=136 Participants
|
|
Brady Arrhythmias:
1st Degree AV Block
|
12 Participants
n=100 Participants
|
6 Participants
n=36 Participants
|
18 Participants
n=136 Participants
|
|
Brady Arrhythmias:
Bradycardia
|
14 Participants
n=100 Participants
|
2 Participants
n=36 Participants
|
16 Participants
n=136 Participants
|
|
Brady Arrhythmias:
2nd Degree AV Block - Permanent
|
10 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
10 Participants
n=136 Participants
|
|
Brady Arrhythmias:
Sinus Arrest
|
7 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=136 Participants
|
|
Brady Arrhythmias:
Chronotropic Incompetence
|
5 Participants
n=100 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=136 Participants
|
|
Brady Arrhythmias:
None
|
6 Participants
n=100 Participants
|
20 Participants
n=36 Participants
|
26 Participants
n=136 Participants
|
|
Cardiac Disease & Arrhythmia HistorY
Hypertension
|
64 Participants
n=100 Participants
|
12 Participants
n=36 Participants
|
76 Participants
n=136 Participants
|
|
Cardiac Disease & Arrhythmia HistorY
Diabetes
|
23 Participants
n=100 Participants
|
11 Participants
n=36 Participants
|
34 Participants
n=136 Participants
|
|
Cardiac Disease & Arrhythmia HistorY
Heart Failure
|
6 Participants
n=100 Participants
|
23 Participants
n=36 Participants
|
29 Participants
n=136 Participants
|
|
Cardiac Disease & Arrhythmia HistorY
Chronic Pulmonary Disease
|
10 Participants
n=100 Participants
|
4 Participants
n=36 Participants
|
14 Participants
n=136 Participants
|
|
Cardiac Disease & Arrhythmia HistorY
Renal Disease
|
5 Participants
n=100 Participants
|
6 Participants
n=36 Participants
|
11 Participants
n=136 Participants
|
|
Cardiac Disease & Arrhythmia HistorY
Other
|
26 Participants
n=100 Participants
|
8 Participants
n=36 Participants
|
34 Participants
n=136 Participants
|
|
Cardiac Disease & Arrhythmia HistorY
None
|
25 Participants
n=100 Participants
|
4 Participants
n=36 Participants
|
29 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: 3 months post implantPopulation: Arms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population. Analysis performed on subjects with paired datasets, each consisting of a commanded RAAT threshold and manual unipolar threshold collected at the 1- and 3-month visits.
Accuracy was evaluated by the proportion of tests resulting in an RAAT commanded threshold with \|Manual unipolar threshold - commanded threshold\| ≤ 0.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted of the manual unipolar threshold and the commanded threshold obtained at a visit.
Outcome measures
| Measure |
RAAT Commanded Threshold
n=190 Paired threshold tests
Subjects with paired RAAT commanded threshold and manual unipolar threshold available
|
|---|---|
|
Accuracy of Commanded Right Atrial Automatic Threshold (RAAT)
|
100 percentage of accurate RAAT tests
Interval 96.8 to 100.0
|
PRIMARY outcome
Timeframe: 90 days post-implantArms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population and both pacemakers and CRT-P devices were pooled for the analysis. The analysis assesses the system-related complication (SRC) -free rate (excluding LV related events for CRT-P subjects) for subjects implanted or attempted to be implanted with a study device through the first 90 days following the implant procedure.
Outcome measures
| Measure |
RAAT Commanded Threshold
n=136 Participants
Subjects with paired RAAT commanded threshold and manual unipolar threshold available
|
|---|---|
|
System-related Complication-free Rate
|
87.5 percentage of subjects free from SRC
Interval 81.8 to 100.0
|
SECONDARY outcome
Timeframe: 3 months post-implantArms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population (pacemaker and CRT-P). Accuracy was evaluated by the proportion of tests resulting in an RAAT ambulatory threshold with \|ambulatory threshold - commanded threshold\| ≤ 1.0V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted consisted of the ambulatory threshold obtained within 7 days prior to the visit and the commanded threshold obtained at the visit.
Outcome measures
| Measure |
RAAT Commanded Threshold
n=187 Paired threshold tests
Subjects with paired RAAT commanded threshold and manual unipolar threshold available
|
|---|---|
|
Accuracy of Ambulatory RAAT
|
186 Paired threshold tests
Interval 182.0 to 187.0
|
SECONDARY outcome
Timeframe: 3 months post-implantArms/Groups are only applicable for the outcome measure 'Secondary Outcome: RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ Programmed to ON vs. RYTHMIQ Programmed to OFF'. This outcome measure was analyzed only for the combined population (pacemaker and CRT-P). Accuracy was evaluated by the proportion of tests with an appropriate commanded RAAT test outcome. An appropriate RAAT outcome consists of either a device-determined threshold or a code indicating that a threshold could not be determined and representing a condition that is beyond the control of the RAAT feature and could occur as well in manual threshold test, such as atrial fibrillation.
Outcome measures
| Measure |
RAAT Commanded Threshold
n=242 threshold tests
Subjects with paired RAAT commanded threshold and manual unipolar threshold available
|
|---|---|
|
Appropriate RAAT Test Outcome
|
84.7 percentage of approprite RAAT tests
Interval 80.4 to 100.0
|
SECONDARY outcome
Timeframe: 3 months post implantPopulation: Pacemaker subjects with RYTHMIQ information available for both randomization periods.
Chronic success is assessed by a median relative reduction of RV pacing percent (RVPP) for RYTHMIQ On at Pre-Discharge, Off at 1-Month vs. RYTHMIQ On at Pre-Discharge, Off at 1-Month. All patients received both RYTHMIQ programmed to ON and programmed to OFF in two consecutive periods, where the patient's programming allocation was randomized for the first period. Then a crossover to the alternate setting occurred for the second period once the end of the first period was reached.
Outcome measures
| Measure |
RAAT Commanded Threshold
n=84 Participants
Subjects with paired RAAT commanded threshold and manual unipolar threshold available
|
|---|---|
|
RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ On at Pre-Discharge, Off at 1-Month vs. RYTHMIQ Off at Pre-discharge, On at 1-Month
RYTHMIQ On
|
4 Percentage of RV pacing
Interval 0.0 to 100.0
|
|
RYTHMIQ - Median Relative Reduction of RV Pacing Percent (RVPP) for RYTHMIQ On at Pre-Discharge, Off at 1-Month vs. RYTHMIQ Off at Pre-discharge, On at 1-Month
RYTHMIQ Off
|
98 Percentage of RV pacing
Interval 1.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 months post implantPopulation: Pooled subjects with a sufficient pacing output voltage to capture the right atrium at the 1-month and the 3-month follow-up visits.
This outcome measure was analyzed only for the combined population (Pacemaker and CRT-P). The sufficient pacing output voltage that is able to capture the right atrium was evaluated by the proportion of Right Atrial Automatic Threshold (RAAT) tests with \[RAAToutput ≥ (max(BP,UP) + δ )\] where BP refers to the manual bipolar threshold, UP refers to the manual unipolar threshold, and δ refers to the safety margin of 0.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for purposes of endpoint analysis. A paired dataset consisted of the commanded threshold and the maximum manual threshold (i.e. the maximum of the manual unipolar and manual bipolar thresholds) obtained at a visit.
Outcome measures
| Measure |
RAAT Commanded Threshold
n=195 Right Atrial Automatic Threshold Tests
Subjects with paired RAAT commanded threshold and manual unipolar threshold available
|
|---|---|
|
Percentage of RAAT Threshold Tests With Sufficient RAAT Pace Output Margin
|
100 Percentage of RAAT w. sufficient output
Interval 98.5 to 100.0
|
Adverse Events
Subjects Implanted With a Study Device or Attempted to be Implanted With a Study Device
Serious adverse events
| Measure |
Subjects Implanted With a Study Device or Attempted to be Implanted With a Study Device
n=136 participants at risk
The study's primary endpoints were designed to assess adverse events for all participants under one category of Cardiac Implantable Electronic Devices (CIED) safety as a unified group. Reporting thus reflects the collective safety profile of CIED interventions as planned and analyzed. This approach was consistent with the study's protocol and objectives, which did not include arm/group-specific AE analysis as a key outcome.
|
|---|---|
|
Product Issues
PG - Oversensing - RV
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Product Issues
PG - Infection (> 30 days post-implant)
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Vascular disorders
Procedure - Venous occlusion
|
1.5%
2/136 • Number of events 2 • 1 year
|
|
Vascular disorders
Hematoma - Pocket (<=30 days post-implant)
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure due to contrast media - Procedure
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Vascular disorders
Venous occlusion
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Product Issues
Venous occlusion
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Vascular disorders
LV - difficult visualization
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Product Issues
Dislodgment - RA
|
2.2%
3/136 • Number of events 4 • 1 year
|
|
Product Issues
Dislodgment - RV
|
0.74%
1/136 • Number of events 2 • 1 year
|
|
Product Issues
Extracardiac stimulation - LV
|
2.8%
1/36 • Number of events 1 • 1 year
|
|
Cardiac disorders
Dyspnea - Heart failure
|
1.5%
2/136 • Number of events 2 • 1 year
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
1.5%
2/136 • Number of events 2 • 1 year
|
|
Cardiac disorders
Multiple heart failure symptoms
|
4.4%
6/136 • Number of events 6 • 1 year
|
|
Cardiac disorders
Atrial Arrhythmias (Heart Failure related)
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pleural Effusion
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation (AF)
|
3.7%
5/136 • Number of events 5 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
1.5%
2/136 • Number of events 2 • 1 year
|
|
Cardiac disorders
Other SVT
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral vascular disease
|
1.5%
2/136 • Number of events 3 • 1 year
|
|
Cardiac disorders
Intermittent claudication
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic regurgitation
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Cardiac disorders
Syncope
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Cardiac disorders
Dizziness
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Cardiac disorders
Chest pain
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cerebrovascular accident (CVA)
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pulmonary embolism
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
General disorders
Adverse Drug Effect
|
0.74%
1/136 • Number of events 2 • 1 year
|
|
General disorders
Chest Pain
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
General disorders
Multiple symptoms
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Product Issues
Death
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
General disorders
Death
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Infections and infestations
Systemic infection
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Physical trauma
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hematological
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Nervous system disorders
Neurological
|
1.5%
2/136 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.2%
3/136 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.5%
2/136 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Genitourinary
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal
|
2.9%
4/136 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.4%
6/136 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Integumentary
|
2.2%
3/136 • Number of events 4 • 1 year
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
Immune system disorders
Immune
|
0.74%
1/136 • Number of events 1 • 1 year
|
|
General disorders
Cancer
|
5.1%
7/136 • Number of events 8 • 1 year
|
|
General disorders
Multi-system failure
|
0.74%
1/136 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Subjects Implanted With a Study Device or Attempted to be Implanted With a Study Device
n=136 participants at risk
The study's primary endpoints were designed to assess adverse events for all participants under one category of Cardiac Implantable Electronic Devices (CIED) safety as a unified group. Reporting thus reflects the collective safety profile of CIED interventions as planned and analyzed. This approach was consistent with the study's protocol and objectives, which did not include arm/group-specific AE analysis as a key outcome.
|
|---|---|
|
Product Issues
Extracardiac stimulation - LV
|
30.6%
11/36 • Number of events 11 • 1 year
|
|
Cardiac disorders
Atrial fibrillation (AF)
|
9.6%
13/136 • Number of events 13 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Consultant (PI) acknowledges and agrees that (i) Consultant shall not publish any data, report, white papers or other materials arising out of the Services performed pursuant to this Agreement without the prior written consent of Boston Scientific, and (ii) any such publication shall not include Boston Scientific Confidential Information except prior written consent of Boston Scientific.
- Publication restrictions are in place
Restriction type: OTHER