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This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The feasibility study is designed to plan and define endpoints for a larger randomized study. The study will assess the HM-parameter trends correlation with daily weight and blood pressure changes. The patient compliance rate of the two different telemonitoring systems (HM & ETM) will also be evaluated.
This single-arm, multi-center feasibility study will explore the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up management of heart failure patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The BIOTRONIK Home Monitoring system will automatically and remotely collect device based information on a daily basis, and an external telemonitoring system will be used to determine the 'weight' and 'blood pressure' remotely at the patient's home on a daily basis. This study will evaluate retrospectively, if Home Monitoring parameters correlate with weight and blood pressure changes. The patient compliance rate of the two telemonitoring systems will also be assessed.
Target enrollment is up to 100 patients at 15 U.S. sites. Patients will be enrolled within a period of 12 to 15 months. Based on the follow-up period of 6 months per patient, the study duration is 18 to 21 months from the date of first patient enrollment. All patients will give written informed consent prior to enrollment and will be implanted with the legally marketed BIOTRONIK Kronos LV-T, or an appropriate BIOTRONIK CRT-D, as well as legally marketed pacing and defibrillation leads. In addition, all patients will be receiving a legally marketed external telemonitoring system to determine weight and blood pressure at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM with weight and BP remote monitoring | Experimental | Device based Home Monitoring and weight and blood pressure remote monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kronos LV-T, Lumax HF-T | Device | Implanted CRT-device sends out device diagnostics (e.g. heart rate, device and lead integrity, patient activity) via CardioMessenger on daily basis. In addition, daily weight and blood pressure readings are taken; remote data are analyzed by investigational sites via the internet on a weekly basis. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. | Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Akar, MD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Scottsdale Cardiology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Monitoring With Weight and BP Remote Monitoring | Device based Home Monitoring with weight and blood pressure (BP) remote monitoring |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Christiana Care Health Services | Wilmington | Delaware | 19718 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Georgia Arrhythmia Consultants | Macon | Georgia | 31201 | United States |
| Loyola University Medical Center | Chicago | Illinois | 60135 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Thoracic & Cardiovascular Institute | Lansing | Michigan | 48910 | United States |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | United States |
| Cleveland Cardiovascular Research Foundation | Cleveland | Ohio | 44126 | United States |
| Pee Dee Cardiology | Florence | South Carolina | 29506 | United States |
| Spartanburg Regional | Spartanburg | South Carolina | 29303 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Home Monitoring With Weight and BP Remote Monitoring | Device based Home Monitoring with weight and blood pressure (BP) remote monitoring |
| 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 | Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. | Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion. | All Enrolled Participants | Posted | Number | Percent of days | 6 months |
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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 | Home Monitoring With Weight and BP Remote Monitoring | Device based Home Monitoring with weight and blood pressure (BP) remote monitoring | 0 | 66 | 12 | 66 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure related Hospitalization | Cardiac disorders | Systematic Assessment | Adverse event with cardiac cause and resulted in or required treatment in hospital or an outatient setting (e.g. emergency room). |
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| Death | General disorders | Systematic Assessment |
| ||
| Complication | Cardiac disorders | Systematic Assessment | Device related adverse event that required an invasive intervention to restore the function of the CRT-system (e.g. lead revision) |
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The investigator agrees to submit copies of any proposed publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may delete any Confidential Information or other proprietary information. In addition, Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katerina de Metz (Director, Clinical Studies) | BIOTRONIK, Inc. | 800-547-0394 | katerina.demetz@biotronik.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Title | Measurements |
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