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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure (HF), Atrial Fibrillation

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Access to HMSC (Home Monitoring Service Center)<br>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 | Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature)<br>* Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring<br>|
| Active Comparator: 2: No access to HMSC<br>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. | Device: Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days Lost | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Clinical Composite Score (Packer Score) | Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms. | 12 months | 
| Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation) | 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 | 12 months | 
| Progression of AF and AT/AF Burden | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT, therapy of AF, telecardiology, home monitoring, cardiovascular hospitalization, cardiovascular mortality