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Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy

NCT00401466 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2011-01-17

No results posted yet for this study

Summary

The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause. The probability of the first therapy due to ventricular tachyarrhythmia was about 34% within 3 years. With a 3-month ICD-follow-up scheme, as it is in the standard ICD therapy, the majority of patients is followed more closely than necessary with respect to anti-tachyarrhythmia ICD therapy.

A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik (Berlin , Germany), for close remote monitoring of ICD patients. The HM function may substitute in-clinic follow-up controls.

The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month follow-up scheme using HM in ICD recipients with the "MADIT II indications". The comparison should be made with respect to the difference in follow-up burden and the associated costs, and regarding possible impact of the remote follow-up via HM on all cause mortality, hospitalization, and patients' quality of life.

Conditions

  • Ventricular Fibrillation
  • Ventricular Tachycardia

Interventions

DEVICE

Implantable Cardioverter Defibrillator

ICD with Biotronik Home Monitoring capability

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Czechia
  • Germany

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 NCT00401466 on ClinicalTrials.gov