TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Able to provide written informed consent
Implanted within the past 45 days or being considered for implant with a BIOTRONIK CRT-D
Age 18 years
Able to follow and comply with the study related procedures
Phone jack with landline connection at home to connect both the BIOTRONIK HM and the ETM system
Sufficient cognitive and reading skills to operate weight & BP system Ambulatory
Weight ≤ 400 lbs

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
HM with weight and BP remote monitoring	Kronos LV-T, Lumax HF-T	Device based Home Monitoring and weight and blood pressure remote monitoring

Primary Outcome Measures

Name	Time	Method
Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.	6 months	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.

Secondary Outcome Measures

Name	Time	Method

Locations (12): St. Louis Heart and Vascular
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St. Louis, Missouri, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Cleveland Cardiovascular Research Foundation
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Cleveland, Ohio, United States
Scottsdale Cardiology
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Scottsdale, Arizona, United States
Georgia Arrhythmia Consultants
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Macon, Georgia, United States
Loyola University Medical Center
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Chicago, Illinois, United States
Thoracic & Cardiovascular Institute
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Lansing, Michigan, United States
Spartanburg Regional
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Spartanburg, South Carolina, United States
Christiana Care Health Services
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Wilmington, Delaware, United States
Pee Dee Cardiology
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Florence, South Carolina, United States
Piedmont Hospital
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Atlanta, Georgia, United States
Maricopa Medical Center
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Phoenix, Arizona, United States