Trial Outcomes & Findings for Model 4396 Left Ventricular (LV) Lead Study (NCT NCT00853593)
NCT ID: NCT00853593
Last Updated: 2019-02-18
Results Overview
A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
One month
Results posted on
2019-02-18
Participant Flow
Participant milestones
| Measure |
Model 4396 LV Lead
Subjects successfully implanted with a Model 4396 LV lead.
|
|---|---|
|
Overall Study
STARTED
|
197
|
|
Overall Study
Implant Attempted
|
193
|
|
Overall Study
Model 4396 Lead Attempted
|
164
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Model 4396 LV Lead
Subjects successfully implanted with a Model 4396 LV lead.
|
|---|---|
|
Overall Study
Subjects did not receive a 4396 lead
|
12
|
|
Overall Study
Model 4396 lead not attempted
|
29
|
|
Overall Study
Implant not attempted
|
4
|
Baseline Characteristics
Model 4396 Left Ventricular (LV) Lead Study
Baseline characteristics by cohort
| Measure |
Model 4396 LV Lead
n=193 Participants
Subjects underwent Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
131 Participants
n=5 Participants
|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
|
New York Heart Association
Class III
|
192 participants
n=5 Participants
|
|
New York Heart Association
Class IV
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity
Black or African American
|
9 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic or Latino
|
6 participants
n=5 Participants
|
|
Race/Ethnicity
Native Hawaiian or Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
White/Caucasian
|
168 participants
n=5 Participants
|
|
Race/Ethnicity
Subject chose not to provide information
|
6 participants
n=5 Participants
|
|
Race/Ethnicity
Other
|
1 participants
n=5 Participants
|
|
Intrinsic QRS Width
|
154.1 Milliseconds
STANDARD_DEVIATION 24.9 • n=5 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
25.7 Percent
STANDARD_DEVIATION 6.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: One monthPopulation: Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.
A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).
Outcome measures
| Measure |
Model 4396 LV Lead
n=163 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Safety (Subjects Without a Model 4396 Lead Related Complication)
|
155 participants
Interval 90.6 to 95.0
|
PRIMARY outcome
Timeframe: One monthPopulation: Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.
Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds \[ms\]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.
Outcome measures
| Measure |
Model 4396 LV Lead
n=139 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Efficacy: Distal Tip Electrode Voltage Threshold
|
1.6 Volts
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Three monthsPopulation: Subjects with ring electrode threshold captured at 0.5 ms at 3-month
Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.
Outcome measures
| Measure |
Model 4396 LV Lead
n=121 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Efficacy: Proximal Ring Voltage Threshold
|
2.3 Volts
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects who underwent Model 4396 LV implant attempt.
A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.
Outcome measures
| Measure |
Model 4396 LV Lead
n=164 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Subjects Successfully Implanted With Model 4396 Lead
|
152 participants
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects with successful CS cannulation after an implant attempt.
A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.
Outcome measures
| Measure |
Model 4396 LV Lead
n=191 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
|
185 participants
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects who underwent an implant attempt.
A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.
Outcome measures
| Measure |
Model 4396 LV Lead
n=193 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Subjects Successfully Implanted With Any Transvenous LV Lead
|
185 participants
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects who underwent an implant attempt.
A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.
Outcome measures
| Measure |
Model 4396 LV Lead
n=193 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
|
183 participants
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects successfully implanted with a Model 4396 lead.
Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.
Outcome measures
| Measure |
Model 4396 LV Lead
n=152 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Cannulation Time
|
6.1 minutes
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects successfully implanted with a Model 4396 lead. Note that one subject's standard fluoroscopy time was not collected and a study deviation was reported.
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Outcome measures
| Measure |
Model 4396 LV Lead
n=151 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Fluoroscopy Time
|
20.6 minutes
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects successfully implanted with a Model 4396 lead. Note that one subject's LV Lead placement time was permanently missing and a study deviation was reported.
Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.
Outcome measures
| Measure |
Model 4396 LV Lead
n=151 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Model 4396 Lead Placement Time
|
13.9 minutes
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects successfully implanted with a Model 4396 lead.
Total operation time was defined as time from initial incision to final closure.
Outcome measures
| Measure |
Model 4396 LV Lead
n=152 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Total Operation Time
|
97.4 minutes
Standard Deviation 41.3
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects who underwent a Model 4396 left ventricular lead implant attempt.
Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.
Outcome measures
| Measure |
Model 4396 LV Lead
n=164 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Assessment of Lead Handling Characteristics Reported as Acceptable
|
162 participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Subjects that were implanted with a Model 4396 lead and completed the 1 month visit
Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds \[ms\]) is less than or equal to 4.0 Volts.
Outcome measures
| Measure |
Model 4396 LV Lead
n=136 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Efficacy: Bipolar Voltage Threshold
|
2.4 Volts
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with tip electrode threshold captured at 0.5 ms at 6 month
Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.
Outcome measures
| Measure |
Model 4396 LV Lead
n=128 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
|
1.5 Volts
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with tip electrode pacing impedance at 6 month
Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
Outcome measures
| Measure |
Model 4396 LV Lead
n=135 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
|
571.2 Ohms
Standard Deviation 155.0
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with tip electrode R-wave amplitude at 6 month
Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.
Outcome measures
| Measure |
Model 4396 LV Lead
n=140 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
|
18.3 mV
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with ring electrode threshold captured at 0.5 ms at 6 month
Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.
Outcome measures
| Measure |
Model 4396 LV Lead
n=121 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
|
2.2 Volts
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with ring electrode pacing impedance at 6 month
Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
Outcome measures
| Measure |
Model 4396 LV Lead
n=134 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
|
544.8 Ohms
Standard Deviation 149.2
|
SECONDARY outcome
Timeframe: During implant procedure.Population: Subjects with ring electrode R-wave amplitude at implant
Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.
Outcome measures
| Measure |
Model 4396 LV Lead
n=140 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
|
17.6 mV
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month
Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.
Outcome measures
| Measure |
Model 4396 LV Lead
n=128 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
|
2.4 Volts
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with bipolar configuration pacing impedance at 6 month
Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.
Outcome measures
| Measure |
Model 4396 LV Lead
n=135 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
|
967.1 Ohms
Standard Deviation 239.2
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Subjects with bipolar configuration electrode R-wave amplitude at 6 month.
Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.
Outcome measures
| Measure |
Model 4396 LV Lead
n=140 Participants
Subjects who underwent a Model 4396 left ventricular lead implant attempt
|
|---|---|
|
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
|
15.0 mV
Standard Deviation 7.3
|
Adverse Events
Model 4396 LV Lead
Serious events: 76 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Model 4396 LV Lead
n=197 participants at risk
Subjects successfully implanted with a Model 4396 LV lead.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Psychiatric disorders
Alcoholic withdrawal symptoms
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Blood and lymphatic system disorders
Anemia
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Aneurysm of aortic arch
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Asystole
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Atrial flutter
|
1.5%
3/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Atrial tachycardia
|
0.51%
1/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Renal and urinary disorders
Bladder cancer
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.5%
3/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Infections and infestations
Central line infection
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Chest pain
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Chest tenderness
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Congestive heart failure
|
0.51%
1/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.5%
3/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Coronary artery disease
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Coronary artery disease aggravated
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Decompensated heart failure
|
7.6%
15/197 • Number of events 17 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Vascular disorders
Deep venous thrombosis arm
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Device lead issue
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Gastrointestinal disorders
Diarrhea
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Infections and infestations
Diverticulitis
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Respiratory, thoracic and mediastinal disorders
Effusion pleural
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Elevated pacing threshold
|
1.5%
3/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Respiratory, thoracic and mediastinal disorders
Embolism pulmonary
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Vascular disorders
Embolus
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Vascular disorders
Femoral artery stenosis
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Fever
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Fever of unknown origin
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Infections and infestations
Foot infection
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Gastrointestinal disorders
GI bleed
|
1.5%
3/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Hematoma
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Herniated disc
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Blood and lymphatic system disorders
Hyperkalaemia
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Vascular disorders
Hypotension
|
1.5%
3/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Endocrine disorders
Hypothyroidism
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Implant site hematoma
|
1.5%
3/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Infections and infestations
Implant site infection
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Inadequate lead connection
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Inappropriate phrenic nerve stimulation
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Metabolism and nutrition disorders
Insulin hypoglycemia
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Intracerebral hemorrhage
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Laceration of head
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
5.1%
10/197 • Number of events 11 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Loss of capture
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Metabolism and nutrition disorders
Loss of control of diabetes
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Middle cerebral artery stroke
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Multiple organ failure
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Near syncope
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
General disorders
Non-cardiac chest pain
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Palpitations
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Vascular disorders
Peripheral vascular disease
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Infections and infestations
Pneumonia
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic hypertrophy
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Infections and infestations
Sepsis
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Spinal column stenosis
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Sudden cardiac death
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Syncope
|
1.0%
2/197 • Number of events 3 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Triple vessel disease
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Twiddler's syndrome
|
1.0%
2/197 • Number of events 2 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Vascular disorders
Uncontrolled hypertension
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Cardiac disorders
Ventricular tachycardia
|
5.1%
10/197 • Number of events 10 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Nervous system disorders
Vertigo
|
0.51%
1/197 • Number of events 1 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
Other adverse events
| Measure |
Model 4396 LV Lead
n=197 participants at risk
Subjects successfully implanted with a Model 4396 LV lead.
|
|---|---|
|
Injury, poisoning and procedural complications
Inappropriate phrenic nerve stimulation
|
5.6%
11/197 • Number of events 15 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
|
Injury, poisoning and procedural complications
Inappropriate stimulation of diaphragm
|
8.1%
16/197 • Number of events 20 • Subject enrollment-exit
Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place