NCT00395642

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

TRIAGE-CRT Telemonitoring in Patients With Congestive Heart Failure and Indication of ICD-Cardiac Resynchronization Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Biotronik, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congestive Heart Failure
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-11-03
• Last updated: 2010-01-20
• Results posted: 2010-01-18

Locations

12 sites across 1 country: United States