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

NCT ID: NCT00811382

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2015-09-30

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.

Conditions

Heart Failure (HF); Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)

Intervention Type: DEVICE

Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring

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.

Group Type: ACTIVE_COMPARATOR

Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)

Intervention Type: DEVICE

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)

Interventions

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

Intervention Type: 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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Schalij, Prof. Dr.

Role: STUDY_CHAIR

Leiden University Medical Center

Isabelle Van Gelder, Prof. Dr.

Role: STUDY_CHAIR

University of Groningen, The Netherlands

Jan Tijssen, Prof. Dr.

Role: STUDY_CHAIR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

A.Z. Middelheim

Antwerp, , Belgium

AZ St. Jan

Bruges, , Belgium

Nemocnice Ceske Budejovice

České Budějovice, , Czechia

FN Olomouc

Olomouc, , Czechia

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

Charitè Berlin

Berlin, , Germany

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, , Germany

University Hospital

Ulm, , Germany

Rijnstate Ziekenhuis

Arnhem, , Netherlands

University Hospital

Groningen, , Netherlands

University Medical Center

Leiden, , Netherlands

Karolinska University Hospital Stockholm

Stockholm, , Sweden

St. Peter's Hospital

Chertsey, , United Kingdom

Countries

Belgium; Czechia; France; Germany; Netherlands; Sweden; United Kingdom

Other Identifiers

HS044

Identifier Type: -

Identifier Source: org_study_id