Optimized Heart Failure Therapy Through Continuous Monitoring (pharao)

Kennemer Gasthuis

Status: Unknown

Conditions: Heart Failure

Treatments: Device: implantable loop recorder Medtronic reveal XT Full view

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01366703

pharao multicentre study

Details and patient eligibility

About

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.

Full description

no additional description needed

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

heart failure patients

Description:

stable heart failure patients, NYHA 1-2, EF \> 35%, no AF, No OAC, CHADS score \>2

Treatment:

Device: implantable loop recorder Medtronic reveal XT Full view