Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure (HF)
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 163
- Locations
- 20
- Primary Endpoint
- Days Lost
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Progression of AF and AT/AF Burden(12 months)
- Heart Failure Clinical Composite Score (Packer Score)(12 months)
- Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)(12 months)