TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
1 other identifier
interventional
66
1 country
12
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2006
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
January 18, 2010
CompletedJanuary 20, 2010
January 1, 2010
1.2 years
November 1, 2006
December 14, 2009
January 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.
Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.
6 months
Study Arms (1)
HM with weight and BP remote monitoring
EXPERIMENTALDevice based Home Monitoring and weight and blood pressure remote monitoring
Interventions
Implanted CRT-device sends out device diagnostics (e.g. heart rate, device and lead integrity, patient activity) via CardioMessenger on daily basis. In addition, daily weight and blood pressure readings are taken; remote data are analyzed by investigational sites via the internet on a weekly basis.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
Study Sites (12)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Scottsdale Cardiology
Scottsdale, Arizona, 85251, United States
Christiana Care Health Services
Wilmington, Delaware, 19718, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Georgia Arrhythmia Consultants
Macon, Georgia, 31201, United States
Loyola University Medical Center
Chicago, Illinois, 60135, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Thoracic & Cardiovascular Institute
Lansing, Michigan, 48910, United States
St. Louis Heart and Vascular
St Louis, Missouri, 63136, United States
Cleveland Cardiovascular Research Foundation
Cleveland, Ohio, 44126, United States
Pee Dee Cardiology
Florence, South Carolina, 29506, United States
Spartanburg Regional
Spartanburg, South Carolina, 29303, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Katerina de Metz (Director, Clinical Studies)
- Organization
- BIOTRONIK, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Akar, MD
Loyola University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2006
First Posted
November 3, 2006
Study Start
November 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
January 20, 2010
Results First Posted
January 18, 2010
Record last verified: 2010-01