Optimized Heart Failure Therapy Through Continuous Monitoring

Study Overview
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Brief Summary
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Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Also home-monitoring is available for continuous monitoring and information sending to the treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever arrhythmia's we hope to improve patient care. Objective of the study: To investigate the clinical efficacy in detecting clinically relevant arrhythmia's (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score >2), currently not treated with oral anticoagulation (OAC). Study design: In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class) 2-3, a CHADS2-score>2 and no indication for a implantable cardioverter-defibrillator (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward clinic visits. The number of relevant arrhythmia's detected will count for the primary endpoint. Also the number of medication changes and institution of OAC. Study population: 50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known. Primary study parameters/outcome of the study: Primary endpoints AF burden and AF episodes detected Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias (VT's) or bradycardias % patients on OAC after 1 year follow-up Number of clinically relevant patient activated events Number of treatment policy changes based on the Reveal XT Secondary study parameters/outcome of the study specificity of AF detection algorithm by the Reveal Predictive value of the cardiac Compass data to predict worsening heart failure episodes.

Detailed Description
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no additional description needed

Official Title
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Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: implantable loop recorder Medtronic reveal XT Full view


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EF > 35% NYHA 2-3 No AF documented Not on OAC Exclusion Criteria: use of OAC documented AF > 30 sec planned or actual PM/ICD life-expectancy < 1 year no informed consent

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| heart failure patients<br>stable heart failure patients, NYHA 1-2, EF > 35%, no AF, No OAC, CHADS score >2 | Device: implantable loop recorder Medtronic reveal XT Full view<br>* Medtronic Reveal implantable loop recorder with home-monitoring using carelink will be implanted in every patient and used to continuously monitor the patients during follow-up to detect symptomatic and asymptomatic arrythmias during follow-up<br>* Other names: Medtronic reveal XT Full view;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| registered arrhythmias with implantable loop recorder during follow-up period | Primary study parameters/outcome of the study: AF burden en AF episodes detected Detected other relevant arrhythmia's like supraventricular tachycardia's (SVT's, not AF) or ventricular tachycardia's (VT's) or bradycardias % patiënts on OAC after 1 year follow-up Number of clinically relevant patient activated events Number of treatment policy changes based on the Reveal XT | 1 year follow-up after last included patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction of worsening heart failure through cardiac compass | Predective value of the cardiac Compass data to predict worsening heart failure episodes. | during follow-up (1 year after last included patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, implantable loop recorder