Phase 4 N=66 Treatment

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

Congestive Heart Failure · Cardiac Resynchronization Therapy

Bottom Line

View on ClinicalTrials.gov: NCT00395642 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. — 71; 71; 83 Percent of days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Kronos LV-T, Lumax HF-T (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Biotronik, Inc.
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.	71; 71; 83	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00395642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.