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

This study has been completed.
Sponsor:
Information provided by:
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00395642
First received: November 1, 2006
Last updated: January 15, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Cardiac Resynchronization Therapy
Device: Kronos LV-T, Lumax HF-T
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TRIAGE-CRT Telemonitoring in Patients With Congestive Heart Failure and Indication of ICD-Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:
  • Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: November 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM with weight and BP remote monitoring
Device based Home Monitoring and weight and blood pressure remote monitoring
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395642

Locations
United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
Scottsdale Cardiology
Scottsdale, Arizona, United States, 85251
United States, Delaware
Christiana Care Health Services
Wilmington, Delaware, United States, 19718
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Georgia Arrhythmia Consultants
Macon, Georgia, United States, 31201
United States, Illinois
Loyola University Medical Center
Chicago, Illinois, United States, 60135
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Thoracic & Cardiovascular Institute
Lansing, Michigan, United States, 48910
United States, Missouri
St. Louis Heart and Vascular
St. Louis, Missouri, United States, 63136
United States, Ohio
Cleveland Cardiovascular Research Foundation
Cleveland, Ohio, United States, 44126
United States, South Carolina
Pee Dee Cardiology
Florence, South Carolina, United States, 29506
Spartanburg Regional
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Biotronik, Inc.
Investigators
Principal Investigator: Joseph Akar, MD Loyola University
  More Information

No publications provided

Responsible Party: Katerina de Metz / Director, Clinical Studies, Biotronik, Inc
ClinicalTrials.gov Identifier: NCT00395642     History of Changes
Other Study ID Numbers: 20061653
Study First Received: November 1, 2006
Results First Received: December 14, 2009
Last Updated: January 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:
Congestive Heart Failure
Cardiac Resynchronization Therapy
Home Monitoring
Telemonitoring
Remote Monitoring

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014