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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00811382
Recruitment Status : Terminated (Criterion according study protocol to end study prematurely was fulfilled.)
First Posted : December 19, 2008
Results First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Heart Failure (HF) Atrial Fibrillation Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature) Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Actual Study Start Date : May 2008
Primary Completion Date : January 2014
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811382


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

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00811382     History of Changes
Other Study ID Numbers: HS044
First Posted: December 19, 2008    Key Record Dates
Results First Posted: March 23, 2017
Last Update Posted: March 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Biotronik SE & Co. KG:
CRT
therapy of AF
telecardiology
home monitoring
cardiovascular hospitalization
cardiovascular mortality

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes