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Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

NCT00538356 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2014-12-23

No results posted yet for this study

Summary

Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure.

To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.

Conditions

  • Ventricular Fibrillation
  • Ventricular Tachycardia
  • Congestive Heart Failure

Interventions

DEVICE

ICD or CRT-D with Home Monitoring feature deactivated

Standard care

DEVICE

ICD or CRT-D with Home Monitoring feature activated

Standard care + patient management by Home Monitoring

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Gerhard Hindricks, Prof. Dr. · Herzzentrum Leipzig, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-03-31
Completion
2013-08-31

Countries

  • Australia
  • Austria
  • Czechia
  • Denmark
  • Germany
  • Israel
  • Latvia

Study Locations

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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 NCT00538356 on ClinicalTrials.gov