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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congestive Heart Failure Cardiac Resynchronization Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HM with weight and BP remote monitoring

Device based Home Monitoring and weight and blood pressure remote monitoring

Group Type EXPERIMENTAL

Kronos LV-T, Lumax HF-T

Intervention Type 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.

Interventions

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Kronos LV-T, Lumax HF-T

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.

Intervention Type DEVICE

Eligibility Criteria

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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