Clinical trial NCT00811382: Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Official title: Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure (HF)
Atrial Fibrillation
Keywords: CRT
therapy of AF
telecardiology
home monitoring
cardiovascular hospitalization
cardiovascular mortality
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Days Lost
timeFrame: 12 months
Secondary outcomes:
measure: Heart Failure Clinical Composite Score (Packer Score)
timeFrame: 12 months
measure: Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)
timeFrame: 12 months
measure: Progression of AF and AT/AF Burden
timeFrame: 12 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: A.Z. Middelheim
city: Brugge
country: Belgium
facility: AZ St. Jan
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice
city: Olomouc
country: Czechia
facility: FN Olomouc
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Lille
country: France
facility: CHRU de Lille
city: Montpellier
country: France
facility: CHRU Hôpital de Villeneuve
city: Nice
country: France
facility: Hôpital Pasteur
city: Paris
country: France
facility: Hôpital La Pitié-Salpetrière
city: Pessac
country: France
facility: CHU Haut Lévêque
city: Rennes
country: France
facility: CHU des Rennes, Hôpital de Pontchaillou
city: Saint Etienne
country: France
facility: Hôpital Nord
city: Toulouse
country: France
facility: Centre Hospitalier de Rangueil
city: Berlin
country: Germany
facility: Charitè Berlin
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden-Friedrichstadt
city: Ulm
country: Germany
facility: University Hospital
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Groningen
country: Netherlands
facility: University Hospital
city: Leiden
country: Netherlands
facility: University Medical Center
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Stockholm
city: Chertsey
country: United Kingdom
facility: St. Peter's Hospital
Study officials:
affiliation: Leiden University Medical Center
name: Martin Schalij, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Groningen, The Netherlands
name: Isabelle Van Gelder, Prof. Dr.
role: STUDY_CHAIR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan Tijssen, Prof. Dr.
role: STUDY_CHAIR
References: