Optimized heart failure therapy through continuous monitoring. The PHARAO multi-centre study

Optimized heart failure therapy through continuous monitoring. The PHARAO multi-centre study - PHARAO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36743

Enrollment

Registered

2011-04-05

Start date

2011-07-08

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: life expectancy

Design outcomes

Primary

Measure	Time frame
Primairy endpoints - AF burden en AF episodes detected - Detected other relevant arrirtmia's like SVT's (not AF) or 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
Secundairy endpoints - specificity of AF detection algorythm by the Reveal - Predective value of the cardiac Compass data to predict worsening heart failure episodes.	—

Countries

Netherlands

Outcome results