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

Purpose

This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure external telemonitoring (ETM) in the follow-up treatment of patients implanted with a 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 IV

MedlinePlus related topics:

Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

Retrospective evaluation of case report forms and telemonitoring data [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Device based Home Monitoring and weight and BP 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 BP 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 and weight and blood pressure telemonitoring 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

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

Locations


United States, South Carolina
	Spartanburg Regional
	Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Biotronik, Inc.

Investigators


Principal Investigator:	Joseph Akar, MD	Loyola University

More Information

Responsible Party:	Biotronik, Inc ( Horst Flathmann, PhD / Clinical Studies Engineer )
Study ID Numbers:	20061653
First Received:	November 1, 2006
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00395642
Health Authority:	United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:

Congestive Heart Failure

Cardiac Resynchronization Therapy

Home Monitoring

Telemonitoring

Remote Monitoring

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Biotronik, Inc.
Information provided by:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00395642