Clinical trial NCT00395642: TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
Official title: TRIAGE-CRT Telemonitoring in Patients With Congestive Heart Failure and Indication of ICD-Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Cardiac Resynchronization Therapy
Keywords: Congestive Heart Failure
Cardiac Resynchronization Therapy
Home Monitoring
Telemonitoring
Remote Monitoring
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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) in the follow-up management of heart failure patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The BIOTRONIK Home Monitoring system will automatically and remotely collect device based information on a daily basis, and an external telemonitoring system will be used to determine the 'weight' and 'blood pressure' remotely at the patient's home on a daily basis. This study will evaluate retrospectively, if Home Monitoring parameters correlate with weight and blood pressure changes. The patient compliance rate of the two telemonitoring systems will also be assessed.

Target enrollment is up to 100 patients at 15 U.S. sites. Patients will be enrolled within a period of 12 to 15 months. Based on the follow-up period of 6 months per patient, the study duration is 18 to 21 months from the date of first patient enrollment. All patients will give written informed consent prior to enrollment and will be implanted with the legally marketed BIOTRONIK Kronos LV-T, or an appropriate BIOTRONIK CRT-D, as well as legally marketed pacing and defibrillation leads. In addition, all patients will be receiving a legally marketed external telemonitoring system to determine weight and blood pressure at home.

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

Primary outcomes:
measure: Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Cardiology
state: Arizona
city: Wilmington
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants
state: Georgia
city: Chicago
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic & Cardiovascular Institute
state: Michigan
city: St. Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Cardiovascular Research Foundation
state: Ohio
city: Florence
country: United States
facility: Pee Dee Cardiology
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional
state: South Carolina
Study officials:
affiliation: Loyola University
name: Joseph Akar, MD
role: PRINCIPAL_INVESTIGATOR
References: