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

Biotronik

Status: Terminated

Conditions: Atrial Fibrillation; Heart Failure (HF)

Treatments: 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 type: Interventional

Funder types: Industry

Identifiers

NCT00811382

HS044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

1: Access to HMSC (Home Monitoring Service Center)

Experimental group

Description:

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

Treatment:

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

2: No access to HMSC

Active Comparator group

Description:

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.

Treatment:

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