Phase 4
Completed N=66
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
Source: ClinicalTrials.gov NCT00395642 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. — 71; 71; 83 Percent of days
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.
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 | — |
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
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. Informational only — not medical advice.