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

Completed · Phase 4

Conditions studied: Congestive Heart Failure, Cardiac Resynchronization Therapy

In brief

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.

Key facts

Study ID

NCT00395642

Run by

Biotronik, Inc.

People needed

66

Starts

2006-11-01

Expected to finish

2008-01-01

Last updated by the study team

2010-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Participation in another cardiovascular clinical study
• Life expectancy <6 months

Where it is running

• Maricopa Medical Center — Phoenix, Arizona, United States
• Scottsdale Cardiology — Scottsdale, Arizona, United States
• Christiana Care Health Services — Wilmington, Delaware, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Georgia Arrhythmia Consultants — Macon, Georgia, United States
• Loyola University Medical Center — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Thoracic & Cardiovascular Institute — Lansing, Michigan, United States
• St. Louis Heart and Vascular — St Louis, Missouri, United States
• Cleveland Cardiovascular Research Foundation — Cleveland, Ohio, United States
• Pee Dee Cardiology — Florence, South Carolina, United States
• Spartanburg Regional — Spartanburg, South Carolina, United States

Full record on ClinicalTrials.gov

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