Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
- Conditions
- Heart Failure (HF)Atrial Fibrillation
- Interventions
- Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)
- Registration Number
- NCT00811382
- Lead Sponsor
- Biotronik SE & Co. KG
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 163
- Indication for CRT with ICD-backup
- Paroxysmal or persistent AF
- Optimized HF-related medication
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2: No access to HMSC Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring) 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. 1: Access to HMSC (Home Monitoring Service Center) Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature) 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
- Primary Outcome Measures
Name Time Method Days Lost 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
Name Time Method Progression of AF and AT/AF Burden 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
Heart Failure Clinical Composite Score (Packer Score) 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) 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
Trial Locations
- Locations (20)
CHRU de Lille
🇫🇷Lille, France
Hôpital Gabriel Montpied
🇫🇷Clermont Ferrand, France
Hôpital La Pitié-Salpetrière
🇫🇷Paris, France
St. Peter's Hospital
🇬🇧Chertsey, United Kingdom
FN Olomouc
🇨🇿Olomouc, Czechia
Hôpital Pasteur
🇫🇷Nice, France
CHU Haut Lévêque
🇫🇷Pessac, France
CHU des Rennes, Hôpital de Pontchaillou
🇫🇷Rennes, France
CHRU Hôpital de Villeneuve
🇫🇷Montpellier, France
Hôpital Nord
🇫🇷Saint Etienne, France
Charitè Berlin
🇩🇪Berlin, Germany
Rijnstate Ziekenhuis
🇳🇱Arnhem, Netherlands
AZ St. Jan
🇧🇪Brugge, Belgium
University Hospital
🇳🇱Groningen, Netherlands
University Medical Center
🇳🇱Leiden, Netherlands
A.Z. Middelheim
🇧🇪Antwerpen, Belgium
Karolinska University Hospital Stockholm
🇸🇪Stockholm, Sweden
Centre Hospitalier de Rangueil
🇫🇷Toulouse, France
Städtisches Klinikum Dresden-Friedrichstadt
🇩🇪Dresden, Germany
Nemocnice Ceske Budejovice
🇨🇿Ceske Budejovice, Czechia