CompletedPhase 4

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

United States66 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.

Timeframe: 6 months

Trial details

NCT IDNCT00395642

SponsorBiotronik, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01

Results submitted2009-12-14

View on ClinicalTrials.gov More Congestive Heart Failure trials