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

Biotronik

Status and phase: Completed; Phase 4

Conditions: Cardiac Resynchronization Therapy; Congestive Heart Failure

Treatments: Device: Kronos LV-T, Lumax HF-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395642

20061653

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

HM with weight and BP remote monitoring

Experimental group

Description:

Device based Home Monitoring and weight and blood pressure remote monitoring

Treatment:

Device: Kronos LV-T, Lumax HF-T