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Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan (J-HomeCARE II)

This study is currently recruiting participants.
Verified February 2012 by Biotronik Japan, Inc.
Sponsor:
Information provided by (Responsible Party):
Biotronik Japan, Inc.
ClinicalTrials.gov Identifier:
NCT01221649
First received: October 12, 2010
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure (HF) related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without heart failure related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.


Condition Intervention Phase
Heart Failure
Arrhythmias, Cardiac
 Device: ICD
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biotronik Japan, Inc.:

Primary Outcome Measures:
  • HF Events [ Time Frame: 21 months follow-up ] [ Designated as safety issue: No ]
    Long-term impedance trends in patients with clinically relevant HF events, to support the development of impedance based detection algorithms. A posterior assessment of sensitivity and false alarm rate of the detection algorithms.


Estimated Enrollment: 195
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ICD
    BIOTRONIK ICD family Lumax 540 and its successors
Detailed Description:

The new BIOTRONIK ICD family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without HF related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.

Lumax is the name of a family of implantable ICDs. The primary objective of the therapy is the prevention of sudden cardiac death. The aim is to automatically detect and terminate cardiac arrest caused by ventricular tachyarrhythmia. All major therapeutical approaches from the field of cardiology and electrophysiology are contained within the Lumax family.

Furthermore, the device is capable of treating bradycardia arrhythmias and congestive heart failure. Congestive heart failure is treated with cardiac resynchronization therapy with multisite ventricular pacing known as cardiac resynchronization therapy (CRT).

The integrated Home Monitoring component can provide information about occurring rhythm disturbances and delivered therapies close to real time as well as by intracardiac electrogram (IEGM) Online HD®. Furthermore, statistical data about the patient's condition as well as information about the integrity status of the implant itself are sent.

The implantation of an ICD is a symptomatic therapy with the following objectives:

Termination of spontaneous ventricular fibrillation (VF) through shock delivery Termination of spontaneous ventricular tachycardia (VT) by means of antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT with shock delivery Cardiac resynchronization by multisite ventricular pacing (triple-chamber implant) Compensation of bradycardia through ventricular (single-chamber implant) or atrioventricular sequential pacing (dual- and triple-chamber implant)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted with a Lumax 540 device or successor
  • New York Heart Association (NYHA)-class II to IV
  • Left ventricular ejection fraction (LVEF) lower or equal to 35%
  • Patient accepts Home Monitoring concept and has sufficient Global System for Mobile Communications (GSM) /General Packet Radio Service (GPRS) net coverage
  • Increased risk for HF-related hospitalization according to pre-defined criteria
  • Patient information
  • Informed consent

Exclusion Criteria:

  • Age < 18 years
  • Contraindication for ICD implantation
  • Post heart transplant (HTX) or actively listed for HTX
  • Cardiac surgery within the previous 3 months or planned at time of inclusion
  • Acute coronary syndrome within the previous 3 months
  • Chronic renal dialysis
  • Pregnant or breast-feeding women
  • Limited contractual capability
  • Participation in another study
  • Anticipated non-compliance with the follow-up scheme
  • Life expectancy not longer than 1.5 years due to a non-cardiac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221649

Contacts
Contact: Hiroshi Shima +81-3-5275-5184 hiroshi.shima@biotronik.co.jp

Locations
Japan
Kokura Kinen Hospital Recruiting
Kitakyushu, Fukuoka, Japan, 802-8555
Contact: Kenji Ando, Dr.            
Yamada Red Cross Hospital Recruiting
Ise, Mie, Japan, 516-0805
Contact: Atsunobu Kasai, Dr.            
Hiroshima Shimin Hospital Recruiting
Hiroshima, Japan
Contact: Fumiharu Miura, Dr.            
Tokyo Women's Medical University Recruiting
Tokyo, Japan
Contact: Morio Shoda, M.D.            
Sponsors and Collaborators
Biotronik Japan, Inc.
Investigators
Principal Investigator: Shoda Morio, DR Tokyo Women's University Hospital
  More Information

No publications provided

Responsible Party: Biotronik Japan, Inc.
ClinicalTrials.gov Identifier: NCT01221649     History of Changes
Other Study ID Numbers: JHC2
Study First Received: October 12, 2010
Last Updated: February 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013