Trial Outcomes & Findings for Detect Fluid Early From Intra-thoracic Impedance Monitoring (NCT NCT00916929)
NCT ID: NCT00916929
Last Updated: 2019-02-19
Results Overview
False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
6-months
Results posted on
2019-02-19
Participant Flow
Patient enrollment began on June 9, 2009 and ended on June 30, 2010. All patients had to be implanted at least 31 days prior to enrollment with a legally marketed St Jude Medical device capable of enabling the impedance monitoring feature.
Participant milestones
| Measure |
Implantable Cardioverter Defibrillator (ICD) Device
Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
|
Cardiac Resynchronization Therapy (CRT-D) Device
Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
82
|
|
Overall Study
COMPLETED
|
70
|
53
|
|
Overall Study
NOT COMPLETED
|
10
|
29
|
Reasons for withdrawal
| Measure |
Implantable Cardioverter Defibrillator (ICD) Device
Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
|
Cardiac Resynchronization Therapy (CRT-D) Device
Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Death
|
5
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Left ventricular epicardial lead
|
1
|
2
|
|
Overall Study
Transferred to hospice care
|
1
|
1
|
|
Overall Study
System explant
|
1
|
0
|
|
Overall Study
Moved to another state
|
0
|
1
|
|
Overall Study
Device unable to process impedance data
|
0
|
7
|
Baseline Characteristics
Detect Fluid Early From Intra-thoracic Impedance Monitoring
Baseline characteristics by cohort
| Measure |
ICD Device
n=80 Participants
Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
|
CRT-D Device
n=82 Participants
Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 14 • n=5 Participants
|
66 years
STANDARD_DEVIATION 13 • n=7 Participants
|
64 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
82 participants
n=7 Participants
|
162 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: All patients participating in the study were included in the analysis with a total of 82 patients in each arm. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D. These 2 patients were censored from the ICD cohort and included in the CRT-D cohort at the time of upgrade based on as-treated analysis principle resulting.
False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.
Outcome measures
| Measure |
Cardiac Resynchronization Therapy (CRT-D) Device
n=84 Participants
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
|
Implantable Cardioverter Defibrillator (ICD) Device
n=80 Participants
Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
|
|---|---|---|
|
False Positive Rate
|
1.8 departures from device threshold
Interval 1.8 to 2.17
|
1.49 departures from device threshold
Interval 1.49 to 1.8
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: All patients enrolled in the study were included in this analysis with a total of 82 patients in each group. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D during data collection period. These 2 patients were censored from ICD cohort and included in CRT-D cohort at the time of upgrade based on as-treated analysis principle.
Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).
Outcome measures
| Measure |
Cardiac Resynchronization Therapy (CRT-D) Device
n=84 Participants
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
|
Implantable Cardioverter Defibrillator (ICD) Device
n=80 Participants
Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
|
|---|---|---|
|
Sensitivity
|
40 percentage of true positives
Interval 26.0 to 40.0
|
30.8 percentage of true positives
Interval 16.3 to 30.8
|
Adverse Events
CRT-D Device
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
ICD Device
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRT-D Device
n=82 participants at risk
Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil
|
ICD Device
n=80 participants at risk
Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
|
|---|---|---|
|
Cardiac disorders
Device Migration
|
1.2%
1/82 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
0.00%
0/80 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Loss of Capture (LV lead related)
|
1.2%
1/82 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
0.00%
0/80 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Lead dislodgement / migration (RV lead related)
|
0.00%
0/82 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
1.2%
1/80 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Infection (system related)
|
0.00%
0/82 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
2.5%
2/80 • Number of events 2 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
Other adverse events
| Measure |
CRT-D Device
n=82 participants at risk
Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil
|
ICD Device
n=80 participants at risk
Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
|
|---|---|---|
|
Cardiac disorders
Elevated Pacing Threshold (LV lead related)
|
1.2%
1/82 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
0.00%
0/80 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Phrenic Nerve / Diaphragmatic Stimulation (LV lead related)
|
1.2%
1/82 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
0.00%
0/80 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Twiddler Syndrome
|
1.2%
1/82 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
0.00%
0/80 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Therapy for Non Ventricular Rhythm
|
3.7%
3/82 • Number of events 3 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
7.5%
6/80 • Number of events 8 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Bleeding / Hematoma
|
0.00%
0/82 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
1.2%
1/80 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
|
Cardiac disorders
Unable to Turn Impedance Data Collection on
|
0.00%
0/82 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
1.2%
1/80 • Number of events 1 • 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60