CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
Kronos LV-T, Lumax HF-Tdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00395642
NCT00395642Phase 4Completed
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TRIAGE-CRT Telemonitoring in Patients With Congestive Heart Failure and Indication of ICD-Cardiac Resynchronization Therapy

Biotronik, Inc.·interventional·Posted Nov 3, 2006·Updated Jan 20, 2010

In Brief

A Phase 4 clinical trial evaluating Kronos LV-T, Lumax HF-T for Congestive Heart Failure and Cardiac Resynchronization Therapy. Completed, enrolled 66 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure, Cardiac Resynchronization Therapy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 2006
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.7 years ago

Interventions

Kronos LV-T, Lumax HF-Tdevice

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.