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To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable Cardioverter Defibrillator (ICD) | Other | Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD). |
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| Cardiac Resynchronization Therapy (CRT-D) | Other | Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impedance Monitoring Feature | Device | Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edwin K Heist, MD, PhD | Massachusetts General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Arizona Arrhythmia Research Center |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Cardiac Resynchronization Therapy (CRT-D) Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Phoenix |
| Arizona |
| 85016 |
| United States |
| Arkansas Cardiology, PA | Little Rock | Arkansas | 72005 | United States |
| Little Rock Cardiology Clinic, PA | Little Rock | Arkansas | 72211 | United States |
| Glendale Memorial Hospital and MC | Glendale | California | 91204 | United States |
| Cardiac Rhythm Specialists, Inc | Northridge | California | 91325 | United States |
| Colorado Cardiac Alliance, LLC | Colorado Springs | Colorado | 80907 | United States |
| Shands Jacksonville | Jacksonville | Florida | 32209 | United States |
| Watson Clinic Center | Lakeland | Florida | 33805 | United States |
| Orlando Heart Center | Orlando | Florida | 32806 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Cardiology Consultants of East Michigan | Flint | Michigan | 48532 | United States |
| Thoracic Cardiovascular HC Found. (Sparrow Research) | Lansing | Michigan | 48910 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Associated Cardiovascular Consultants | Cherry Hill | New Jersey | 08034 | United States |
| New York Presbyterian Hospital / Cornell University | New York | New York | 10021 | United States |
| Mid Carolina Cardiology | Charlotte | North Carolina | 28204 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Mercy Hospital Fairfield | Fairfield | Ohio | 45014 | United States |
| Saint Vincent Consultants in Cardiovascular Diseases | Erie | Pennsylvania | 16502 | United States |
| Hospital of the University of PA | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| St Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| The Hope Heart Institute | Bellevue | Washington | 98004 | United States |
Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ICD Device | Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | departures from device threshold | 6-months |
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| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of true positives | 6-months |
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755.98 patient months for CRT-D cohort; 902.37 patient months for ICD cohort
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 2 | 82 | 6 | 82 | ||
| EG001 | ICD Device | Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil | 3 | 80 | 8 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Migration | Cardiac disorders | Systematic Assessment |
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| Loss of Capture (LV lead related) | Cardiac disorders | Systematic Assessment |
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| Lead dislodgement / migration (RV lead related) | Cardiac disorders | Systematic Assessment |
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| Infection (system related) | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Pacing Threshold (LV lead related) | Cardiac disorders | Systematic Assessment |
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| Phrenic Nerve / Diaphragmatic Stimulation (LV lead related) | Cardiac disorders | Systematic Assessment |
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| Twiddler Syndrome | Cardiac disorders | Systematic Assessment |
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| Therapy for Non Ventricular Rhythm | Cardiac disorders | Systematic Assessment |
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| Bleeding / Hematoma | Cardiac disorders | Systematic Assessment |
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| Unable to Turn Impedance Data Collection on | Cardiac disorders | Systematic Assessment |
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There were no limitations of the trial.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Shipman | St Jude Medical | 408 522-6410 | tshipman@sjm.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Male |
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