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

December 18, 2008
February 27, 2013
May 2008
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00811382 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Atrial Fibrillation
  • 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)
  • 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
    Intervention: Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature)
  • 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.
    Intervention: Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
300
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Czech Republic,   Sweden,   Netherlands,   United Kingdom
 
NCT00811382
HS044
Yes
Biotronik SE & Co. KG
Biotronik SE & Co. KG
Not Provided
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
Biotronik SE & Co. KG
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP