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

Congestive Heart Failure Clinical Trial

Official title:

TRIAGE-CRT Telemonitoring in Patients With Congestive Heart Failure and Indication of ICD-Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395642
• Other study ID #: 20061653
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2006
• Last updated: January 15, 2010
• Start date: November 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2010
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Kronos LV-T, Lumax HF-T
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.		6 months	No