Optimized heart failure therapy through continuous monitoring. The PHARAO multi-centre study
Completed
- Conditions
- heart failure10019280
- Registration Number
- NL-OMON36743
- Lead Sponsor
- Kennemer Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
heart failure
objective systolic or diastolic heart failure
NYHA 2-3
CHADS score 2 or more
No indication ICD/PM or OAC
No atrial fibrillation
No planned or expected revascularisation or valveoperation < 3 months
Exclusion Criteria
life expectancy < 1 year
No informed concent
Participation in other study
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primairy endpoints<br /><br><br /><br>- AF burden en AF episodes detected<br /><br>- Detected other relevant arrirtmia's like SVT's (not AF) or VT's or<br /><br>bradycardias<br /><br>- % patiënts on OAC after 1 year follow-up<br /><br>- Number of clinically relevant patient activated events<br /><br>- Number of treatment policy changes based on the Reveal XT </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundairy endpoints<br /><br><br /><br>- specificity of AF detection algorythm by the Reveal<br /><br>- Predective value of the cardiac Compass data to predict worsening heart<br /><br>failure episodes.</p><br>