NCT00395642
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
PHASE4
COMPLETED
NCT00395642
INTERVENTIONAL
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.
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:
* Participation in another cardiovascular clinical study
* Life expectancy \<6 months
Congestive Heart Failure
Cardiac Resynchronization Therapy
- TREATMENT
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- Type: DEVICE
- Name: Kronos LV-T, Lumax HF-T
- Description: 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.
- Arm Group Labels: HM with weight and BP remote monitoring
- Biotronik, Inc.