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

August 6, 2024 updated by: Biotronik SE & Co. KG
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

300 patients with a documented history of AF will be enrolled and randomized 1:1 to standard patient management or AF management and early optimization of CRT via Home Monitoring. The patient outcome regarding days lost due to cardiovascular mortality, cardiovascular hospitalization and inappropriate ICD therapy will be documented during an observational period of 1 year.

Another 300 patients undergoing CRT-ICD implantation without a history of AF will undergo an AF evaluation during the first three months of CRT. If a patient shows an AF episode during this period, he is eligible for study inclusion. If no AF episode occurs during AF evaluation, the patient be treated as screening failure.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • A.Z. Middelheim
      • Brugge, Belgium
        • AZ St. Jan
  • Czechia
      • Ceske Budejovice, Czechia
        • Nemocnice Ceske Budejovice
      • Olomouc, Czechia
        • FN Olomouc
  • France
      • Clermont Ferrand, France
        • Hopital Gabriel Montpied
      • Lille, France
        • CHRU de Lille
      • Montpellier, France
        • CHRU Hôpital de Villeneuve
      • Nice, France
        • Hôpital Pasteur
      • Paris, France
        • Hôpital La Pitié-Salpétrière
      • Pessac, France
        • CHU Haut Lévêque
      • Rennes, France
        • CHU des Rennes, Hôpital de Pontchaillou
      • Saint Etienne, France
        • Hôpital Nord
      • Toulouse, France
        • Centre Hospitalier de Rangueil
  • Germany
      • Berlin, Germany
        • Charite Berlin
      • Dresden, Germany
        • Städtisches Klinikum Dresden-Friedrichstadt
      • Ulm, Germany
        • University Hospital
  • Netherlands
      • Arnhem, Netherlands
        • Rijnstate Ziekenhuis
      • Groningen, Netherlands
        • University Hospital
      • Leiden, Netherlands
        • University Medical Center
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital Stockholm
  • United Kingdom
      • Chertsey, United Kingdom
        • St. Peter's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Indication for CRT with ICD-backup
  • Paroxysmal or persistent AF
  • Optimized HF-related medication

Exclusion Criteria:

  • Permanent AF
  • Contraindication for anticoagulation
  • Stroke within the last 6 weeks
  • Acute coronary syndrome within the last 2 months
  • Cardiac surgery within the last 2 months
  • Acute myocarditis
  • Severe chronic obstructive pulmonary disease (COPD)
  • Planned cardiac surgery or interventional measures within the coming 3 months
  • Dialysis dependency
  • Life expectancy < 12 months
  • Insufficient GSM (Global System for Mobile Communication)/GPRS (General Packet Radio Service)-network coverage
  • Previously implanted unipolar right atrial lead
  • Previously implanted right atrial lead with tip-ring distance > 11 mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Access to HMSC (Home Monitoring Service Center)
Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC
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
Active Comparator: 2: No access to HMSC
Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days Lost
Time Frame: 12 months
Clinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Clinical Composite Score (Packer Score)
Time Frame: 12 months
Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.
12 months
Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)
Time Frame: 12 months
Analysis of the change in left ventricular end-systolic volume, left atrial diameter, left ventricular EF, and the degree of mitral regurgitation from enrollment to the end of the follow-up in the two treatment arms
12 months
Progression of AF and AT/AF Burden
Time Frame: 12 months
The proportion of patients in sinus rhythm or with paroxysmal AF, persistant AF, or permanet AF at the end of the Follow-Up, without statistical evaluation and analysis of AF/AT (atrial tachycardia) burden based on the home monitoring data
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Study Chair: Martin Schalij, Prof. Dr., Leiden University Medical Center
  • Study Chair: Isabelle Van Gelder, Prof. Dr., University of Groningen, The Netherlands
  • Study Chair: Jan Tijssen, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimated)

December 19, 2008

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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