Optimized Heart Failure Therapy Through Continuous Monitoring
- Conditions
- Heart Failure
- Interventions
- Device: implantable loop recorder Medtronic reveal XT Full view
- Registration Number
- NCT01366703
- Lead Sponsor
- Kennemer Gasthuis
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- EF > 35%
- NYHA 2-3
- No AF documented
- Not on OAC
- use of OAC
- documented AF > 30 sec
- planned or actual PM/ICD
- life-expectancy < 1 year
- no informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description heart failure patients implantable loop recorder Medtronic reveal XT Full view stable heart failure patients, NYHA 1-2, EF \> 35%, no AF, No OAC, CHADS score \>2
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (5)
Kennemer gasthuis
🇳🇱Haarlem, Netherlands
Rijnland Ziekenhuis
🇳🇱Leiderdorp, Netherlands
Rijnstate ziekenhuis
🇳🇱Arnhem, Netherlands
Deventer Ziekenhuis
🇳🇱Deventer, Netherlands
Martini Ziekenhuis
🇳🇱Groningen, Netherlands