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Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

NCT00811382 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2024-08-29

Study results available
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Summary

EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator (ICD) backup and AF.

Conditions

Interventions

DEVICE

Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)

Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring

DEVICE

Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)

Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Martin Schalij, Prof. Dr. · Leiden University Medical Center

  • Isabelle Van Gelder, Prof. Dr. · University of Groningen, The Netherlands

  • Jan Tijssen, Prof. Dr. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2014-01-31
Completion
2015-09-30

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Netherlands
  • Sweden
  • United Kingdom

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 NCT00811382 on ClinicalTrials.gov