An interventional study of Impedance Monitoring Feature in Heart Failure, sponsored by Abbott Medical Devices. Completed at 34 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Diagnostic
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 162 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).
Device: Impedance Monitoring Feature
Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.
Device: Impedance Monitoring Feature
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
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
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
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.
| Milestone | Implantable Cardioverter Defibrillator (ICD) Device | Cardiac Resynchronization Therapy (CRT-D) Device |
|---|---|---|
| Started | 80 | 82 |
| Completed | 70 | 53 |
| Not completed | 10 | 29 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Death | 5 | 10 |
| Withdrew: Withdrawal by subject | 1 | 5 |
| Withdrew: Left ventricular epicardial lead | 1 | 2 |
| Withdrew: Transferred to hospice care | 1 | 1 |
| Withdrew: System explant | 1 | 0 |
| Withdrew: Moved to another state | 0 | 1 |
| Withdrew: Device unable to process impedance data | 0 | 7 |
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.
| departures from device threshold | Cardiac Resynchronization Therapy (CRT-D) Device | Implantable Cardioverter Defibrillator (ICD) Device |
|---|---|---|
| False Positive Rate | 1.8 (1.8 to 2.17) | 1.49 (1.49 to 1.8) |
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).
| percentage of true positives | Cardiac Resynchronizaiton Therapy (CRT-D) Device | Implantable Cardioverter Defibrillator (ICD) Device |
|---|---|---|
| Sensitivity | 40 (26 to 40) | 30.8 (16.3 to 30.8) |
Collected over 755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CRT-D Device | — | 2/82 (2.4%) | 6/82 (7.3%) |
| ICD Device | — | 3/80 (3.8%) | 8/80 (10%) |
| Event | CRT-D Device | ICD Device |
|---|---|---|
| Infection (system related)Cardiac disorders | 0/82 | 2/80 |
| Lead dislodgement / migration (RV lead related)Cardiac disorders | 0/82 | 1/80 |
| Device MigrationCardiac disorders | 1/82 | 0/80 |
| Loss of Capture (LV lead related)Cardiac disorders | 1/82 | 0/80 |
| Event | CRT-D Device | ICD Device |
|---|---|---|
| Therapy for Non Ventricular RhythmCardiac disorders | 3/82 | 6/80 |
| Bleeding / HematomaCardiac disorders | 0/82 | 1/80 |
| Unable to Turn Impedance Data Collection onCardiac disorders | 0/82 | 1/80 |
| Elevated Pacing Threshold (LV lead related)Cardiac disorders | 1/82 | 0/80 |
| Phrenic Nerve / Diaphragmatic Stimulation (LV lead related)Cardiac disorders | 1/82 | 0/80 |
| Twiddler SyndromeCardiac disorders | 1/82 | 0/80 |
| Age, Categorical(Participants) | ICD Device | CRT-D Device | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 44 | 36 | 80 |
| >=65 years | 36 | 46 | 82 |
| Age, Continuous(years) | ICD Device | CRT-D Device | Total |
|---|---|---|---|
| Mean | 61 ± 14 | 66 ± 13 | 64 ± 13 |
| Sex: Female, Male(Participants) | ICD Device | CRT-D Device | Total |
|---|---|---|---|
| Female | 32 | 13 | 45 |
| Male | 48 | 69 | 117 |
| Region of Enrollment(participants) | ICD Device | CRT-D Device | Total |
|---|---|---|---|
| United States | 80 | 82 | 162 |
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abbott Medical Devices