MedTrace Logo

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

NCT01221649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2015-10-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

ICD/CRT-D

BIOTRONIK ICD family Lumax 540 and its successors

Sponsors & Collaborators

  • Biotronik Japan, Inc.

    lead INDUSTRY

Principal Investigators

  • Shoda Morio, DR · Tokyo Women's University Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221649 on ClinicalTrials.gov