Heart Failure
Conditions
Brief summary
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
Interventions
DEVICEImpedance Monitoring Feature
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days * Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months
Exclusion criteria
* History of kidney disease requiring hemodialysis * Refractory end stage heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| False Positive Rate | 6-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 6-months | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ICD Device Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil | 80 |
| CRT-D Device Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil. | 82 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 10 |
| Overall Study | Device unable to process impedance data | 0 | 7 |
| Overall Study | Left ventricular epicardial lead | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Moved to another state | 0 | 1 |
| Overall Study | System explant | 1 | 0 |
| Overall Study | Transferred to hospice care | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | CRT-D Device | ICD Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 36 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 44 Participants | 80 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 13 | 61 years STANDARD_DEVIATION 14 | 64 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 82 participants | 80 participants | 162 participants |
| Sex: Female, Male Female | 13 Participants | 32 Participants | 45 Participants |
| Sex: Female, Male Male | 69 Participants | 48 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 82 | 8 / 80 |
| serious Total, serious adverse events | 2 / 82 | 3 / 80 |
Outcome results
Primary
False Positive Rate
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.
Time frame: 6-months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT-D) Device | False Positive Rate | 1.8 departures from device threshold |
| Implantable Cardioverter Defibrillator (ICD) Device | False Positive Rate | 1.49 departures from device threshold |
Comparison: For each patient cohort, the hypothesis is formally expressed as follows:~H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate \<1.5 per patient-year of follow-up~The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up.exact method
Secondary
Sensitivity
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).
Time frame: 6-months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT-D) Device | Sensitivity | 40 percentage of true positives |
| Implantable Cardioverter Defibrillator (ICD) Device | Sensitivity | 30.8 percentage of true positives |
Comparison: For each patient cohort, the hypothesis is formally expressed as follows:~H0: Sensitivity ≤ 50% Ha: Sensitivity \> 50%~The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%.exact method