Status:
COMPLETED
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
Lead Sponsor:
Biotronik, Inc.
Conditions:
Congestive Heart Failure
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 tre...
Detailed Description
This single-arm, multi-center feasibility study will explore the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM)...
Eligibility Criteria
Inclusion
- 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
- Participation in another cardiovascular clinical study
- Life expectancy \<6 months
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00395642
Start Date
November 1 2006
End Date
January 1 2008
Last Update
January 20 2010
Active Locations (12)
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1
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
2
Scottsdale Cardiology
Scottsdale, Arizona, United States, 85251
3
Christiana Care Health Services
Wilmington, Delaware, United States, 19718
4
Piedmont Hospital
Atlanta, Georgia, United States, 30309