Trial Outcomes & Findings for Evaluation of Automatic Threshold Algorithms (NCT NCT02097290)
NCT ID: NCT02097290
Last Updated: 2018-04-19
Results Overview
Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
3 months
Results posted on
2018-04-19
Participant Flow
Participant milestones
| Measure |
CRT-D
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
Overall Study
STARTED
|
210
|
|
Overall Study
COMPLETED
|
193
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
CRT-D
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Total Withdrawals
|
3
|
|
Overall Study
Attempt
|
8
|
Baseline Characteristics
Evaluation of Automatic Threshold Algorithms
Baseline characteristics by cohort
| Measure |
CRT-D
n=210 Participants
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
170 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Undisclosed
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
210 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Implant + Attempt Subjects
Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
Outcome measures
| Measure |
CRT-D
n=210 Participants
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
|
84.2 Percentage of participants
Interval 79.5 to
Only lower confidence interval limit was considered for end point result
|
PRIMARY outcome
Timeframe: 1-month and 3-month follow-up visitsPopulation: A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: \|commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. 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 the purpose of this endpoint analysis.
Outcome measures
| Measure |
CRT-D
n=288 Commanded RVAT thresholds paired dataset
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
|
97.9 percentage of commanded RVAT thresholds
Interval 95.9 to
Only lower confidence interval limit was considered for end point result
|
PRIMARY outcome
Timeframe: 1-month and 3-month follow up visitsPopulation: A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold\| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or \|commanded threshold - core lab determined threshold\| ≤ 0.5 V; if the commanded threshold is \> 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. 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 the purpose of this endpoint analysis.
Outcome measures
| Measure |
CRT-D
n=324 Commanded LVAT thresholds-paired dataset
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
|
97.8 Percentage of commanded LVAT thresholds
Interval 96.0 to
Only lower confidence interval limit was considered for end point result
|
PRIMARY outcome
Timeframe: 1-month and 3-month follow up visitsPopulation: A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:\|Ambulatory threshold - ECG threshold\| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V; if the ECG threshold is \> 3.5V. 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 form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Outcome measures
| Measure |
CRT-D
n=314 RVAT ambulatory threshold paired dataset
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
|
99.0 Percentage of RVAT ambulatory thresholds
Interval 97.5 to
Only lower confidence interval limit was considered for end point result
|
PRIMARY outcome
Timeframe: 1-month and 3-month follow up visitsPopulation: A total of 300 paired datasets (from 175 unique subjects in whom LVAT threshold was available), each dataset consisting of a ambulatory LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.
Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: \|Ambulatory threshold - ECG threshold\| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. 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 form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Outcome measures
| Measure |
CRT-D
n=300 LVAT ambulatory threshold paired dataset
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
|
97.7 Percentage of accurate threshold
Interval 95.7 to
Only lower confidence interval limit was considered for end point result
|
SECONDARY outcome
Timeframe: 3-month follow up visitPopulation: A total of 157 unique subjects in whom a paired RVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an RVAT threshold test outcome and core lab determined threshold test outcome.
This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: 1. A device-determined threshold 2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests 3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.
Outcome measures
| Measure |
CRT-D
n=157 Participants
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
|
85.4 percentage of appropriate outcome
Interval 79.9 to
Only lower confidence interval limit was considered for end point result
|
SECONDARY outcome
Timeframe: 3-month follow up visitPopulation: A total of 182 unique subjects in whom a paired LVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an LVAT threshold test outcome and core lab determined threshold test outcome.
This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: 1. A device-determined threshold 2. A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests 3. A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.
Outcome measures
| Measure |
CRT-D
n=182 Participants
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
|
|---|---|
|
LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
|
95.1 percentage of appropriate outcome
Interval 91.5 to
Only lower confidence interval limit was considered for end point result
|
Adverse Events
CRT-D
Serious events: 101 serious events
Other events: 81 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
CRT-D
n=210 participants at risk
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated.
Subjects in whom AUTOGEN CRT-D was successfully implanted or an attempt to implant made were considered to be at risk for adverse events. There were a total of 210 implants and attempts.
|
|---|---|
|
Blood and lymphatic system disorders
Abnormal Laboratory Values
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Adverse Reaction - Hypotension
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Adverse Reaction - Respiratory
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Arterial/Venous Trombolytic Event
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Atrial Fibrillation (Af)
|
3.3%
7/210 • Number of events 8 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
2.4%
5/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Atrial Tachyarrhythmias
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.9%
4/210 • Number of events 4 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Cardiac Arrest
|
3.8%
8/210 • Number of events 8 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Vascular disorders
Cerebrovascular Accident (Cva)
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Chest Pain - Ischemic
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Chest Pain - Other
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Copd Exacerbation
|
1.4%
3/210 • Number of events 4 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.48%
1/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Coronary Venous Perforation Without Tamponade
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment - Elevated Threshold - Rv
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment - Extracardiac Stimulation - Lv
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment - Multiple Signs - Rv
|
0.48%
1/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment - No Reported Signs - Lv
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment - No Reported Signs - Ra
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment - Unable To Capture - Lv
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment - Unable To Capture - Ra
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Dizziness
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
4.3%
9/210 • Number of events 13 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Elevated Threshold - Lv
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Endocrine disorders
Endocrine
|
1.9%
4/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Extracardiac Stimulation - Lv
|
2.4%
5/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal
|
6.7%
14/210 • Number of events 17 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Gastrointestinal - Heart Failure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Renal and urinary disorders
Genitourinary
|
3.3%
7/210 • Number of events 7 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Eye disorders
Cataract
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Heart Failure Symptoms - Unspecified
|
2.9%
6/210 • Number of events 6 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Blood and lymphatic system disorders
Hematological
|
1.9%
4/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Hematoma - Pocket (<=30 Days Post-Implant)
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Hypotension
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Hypotension - Heart Failure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Impedance < 300 Ohms - Ra
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Inadvertent Vt/Vf
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Inappropriate Tachy Therapy - Svt
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Infections and infestations
Infection (> 3 Days Post-Implant)
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Ear and labyrinth disorders
Migration
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Mitral Regurgitation
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Immune system disorders
Multi-System Failure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Multi-System Failure - Heart Failure
|
2.4%
5/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
11.9%
25/210 • Number of events 34 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Immune system disorders
Multiple Symptoms
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
1.9%
4/210 • Number of events 6 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Myocardial Infarction
|
1.9%
4/210 • Number of events 4 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Myocardial Perforation Post-Implant - Rv
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Myocardial Perforation With Tamponade
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Nervous system disorders
Neurological
|
1.9%
4/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Other-Lead-Procedure
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Palpitations
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Pericardial Effusion
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Peripheral Edema - Heart Failure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Vascular disorders
Peripheral Vascular Disease
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Musculoskeletal and connective tissue disorders
Physical Trauma
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Pleural Effusion
|
0.48%
1/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Pneumothorax - Procedure
|
1.9%
4/210 • Number of events 4 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Post-Surgical Wound Discomfort
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Premature Ventricular Contractions (Pvc)
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Psychiatric disorders
Psychological
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
6.7%
14/210 • Number of events 23 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema - Heart Failure
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Renal and urinary disorders
Renal
|
3.3%
7/210 • Number of events 8 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Renal and urinary disorders
Renal Failure Due To Contrast Media - Procedure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Renal and urinary disorders
Renal Insufficiency - Heart Failure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Syncope
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Infections and infestations
Systemic Infection
|
1.9%
4/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Unable To Capture - Lv
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Unable To Convert - Defibrillation
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Ventricular Fibrillation (Vf)
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Ventricular Flutter
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia (Vt)
|
1.4%
3/210 • Number of events 4 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Failure To Implant Epicardial Lv Lead
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Inability To Place The Lv Lead
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Left Chest Wall Emphysema
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Vascular disorders
Left Leg Ischemia
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
ICD shocks
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Infections and infestations
Severe Rt. Leg Stump Infection
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Unable To Insert Lv Lead With Initial Procedure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Ear and labyrinth disorders
Vestibulitis
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Angioedema
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Patient Death - unknown cause
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
Other adverse events
| Measure |
CRT-D
n=210 participants at risk
CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated.
Subjects in whom AUTOGEN CRT-D was successfully implanted or an attempt to implant made were considered to be at risk for adverse events. There were a total of 210 implants and attempts.
|
|---|---|
|
General disorders
Abnormal Laboratory Values
|
3.3%
7/210 • Number of events 10 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Allergic Reaction
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Delirium
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Hypotension
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.2%
11/210 • Number of events 12 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Atrial Tachyarrhythmias
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Unable to perform Threshold test-RV
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Chest Pain-Ischemic
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Chest Pain-Other
|
2.4%
5/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Coronary Venous Dissection
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment-extracardiac stimulation-RA
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment-LV
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment-unable to capture-LV
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dislodgment-unable to capture-RV
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Dizziness
|
1.9%
4/210 • Number of events 4 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Dyspnea-heart failure
|
1.4%
3/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Endocrine disorders
Endocrine
|
2.4%
5/210 • Number of events 5 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Extracardiac stimulation-LV
|
13.3%
28/210 • Number of events 30 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Fatigue
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal
|
3.8%
8/210 • Number of events 10 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Renal and urinary disorders
Genitorurinary
|
4.8%
10/210 • Number of events 11 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Eye disorders
Visual disturbances
|
0.95%
2/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Blood and lymphatic system disorders
Hematological
|
2.9%
6/210 • Number of events 6 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Hematoma (less than 30 days post implant)
|
3.3%
7/210 • Number of events 7 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Hypertension
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Immune system disorders
Immune disorder
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Insulation breach-RV
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
3.8%
8/210 • Number of events 8 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Mitral regurgitation
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
2.4%
5/210 • Number of events 7 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal
|
6.7%
14/210 • Number of events 16 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Myocardial Infarction
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Nervous system disorders
Neurological
|
1.4%
3/210 • Number of events 4 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Nonsustained Ventricular Tachycardia
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Other PG-system-procedure
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Cardiovascular event
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Oversensing-RV
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Pacemaker Mediated Tachycardia
|
3.8%
8/210 • Number of events 8 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Palpitations
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Peripheral edema-heart failure
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Vascular disorders
Peripheral vascular disease
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
PG system-event
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Musculoskeletal and connective tissue disorders
Physical Trauma
|
5.2%
11/210 • Number of events 12 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Infections and infestations
Post surgical infection
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Post-surgical Pocket Hemorhage
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Post-surgical wound discomfort
|
4.3%
9/210 • Number of events 9 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Premature ventricular contractions
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Psychiatric disorders
Psychological
|
0.95%
2/210 • Number of events 3 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Psychiatric disorders
Psychological effect due to device therapy
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
6.7%
14/210 • Number of events 14 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Renal and urinary disorders
Renal
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Syncope
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Thromboembolic events
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Transient Ischemic Attack
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Unable to capture-LV lead
|
0.95%
2/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Undersensing-RA
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Vascular disorders
Venous Occlusion
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Ventricular Tacchyarrhythmias
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Weight Gain
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Adverse Drug Reaction
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
General disorders
Cocaine Abuse
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Ear and labyrinth disorders
Ear reaction
|
0.48%
1/210 • Number of events 2 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Skin and subcutaneous tissue disorders
Swollen neck
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
ICD shocks
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Low LVEF
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
High LV lead impedance
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
High RV lead impedance
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
|
Cardiac disorders
Low pacing output
|
0.48%
1/210 • Number of events 1 • Adverse events reported were collected from ICF signature until the last study follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60