Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT) (effecT)
|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)|
|Study Design:||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)|
- 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.
- 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.
- 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
- 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
|Actual Study Start Date:||May 2008|
|Study Completion Date:||September 2015|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811382
|AZ St. Jan|
|Nemocnice Ceske Budejovice|
|Ceske Budejovice, Czech Republic|
|Olomouc, Czech Republic|
|Hôpital Gabriel Montpied|
|Clermont Ferrand, France|
|CHRU de Lille|
|CHRU Hôpital de Villeneuve|
|Hôpital La Pitié-Salpetrière|
|CHU Haut Lévêque|
|CHU des Rennes, Hôpital de Pontchaillou|
|Saint Etienne, France|
|Centre Hospitalier de Rangueil|
|Städtisches Klinikum Dresden-Friedrichstadt|
|University Medical Center|
|Karolinska University Hospital Stockholm|
|St. Peter's Hospital|
|Chertsey, United Kingdom|
|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)|