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

This study has suspended participant recruitment.
(Criterion according to CIP to end study prematurely was fulfilled. Enrolled patients are followed-up normally.)
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00811382
First received: December 18, 2008
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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 and atrial fibrillation.


Condition Intervention
Heart Failure
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Clinical composite outcome based on the days lost during 1 year due to: cardiovascular mortality, cardiovascular hospitalization, inappropriate ICD therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart Failure Clinical Composite Score (Packer Score) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reverse remodelling (LA diameter, LVESV, mitral regurgitation) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression of AF and AT/AF burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Access to HMSC
Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center
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)

Detailed Description:

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 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Planned cardiac surgery or interventional measures within the coming 3 months
  • Dialysis dependency
  • Life expectancy < 12 months
  • Insufficient GSM/GPRS-network coverage
  • Previously implanted unipolar right atrial lead
  • Previously implanted right atrial lead with tip-ring distance > 11 mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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. Academic Medical Center, Amsterdam, The Netherlands
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00811382     History of Changes
Other Study ID Numbers: HS044
Study First Received: December 18, 2008
Last Updated: February 27, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Biotronik SE & Co. KG:
cardiac resynchronization therapy
therapy of atrial fibrillation
telecardiology
home monitoring
cardiovascular hospitalization
cardiovascular mortality

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

ClinicalTrials.gov processed this record on July 23, 2014