Heart Failure
Conditions
Keywords
heart failure, implantable loop recorder
Brief summary
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
no additional description needed
Interventions
DEVICEimplantable loop recorder Medtronic reveal XT Full view
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
Sponsors
Medtronic
Kennemer Gasthuis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| registered arrhythmias with implantable loop recorder during follow-up period | 1 year follow-up after last included patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prediction of worsening heart failure through cardiac compass | during follow-up (1 year after last included patient) | Predective value of the cardiac Compass data to predict worsening heart failure episodes. |
Countries
Netherlands
Contacts
Primary Contactraymond tukkie, MD PhD
Backup ContactRobert Tieleman, MD PhD
Outcome results
None listed