Congestive Heart Failure Clinical Trial
Official title:
TRIAGE-CRT Telemonitoring in Patients With Congestive Heart Failure and Indication of ICD-Cardiac Resynchronization Therapy
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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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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