Optimized Heart Failure Therapy Through Continuous Monitoring

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

no additional description needed ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Heart Failure

Clinical Trial Details

NCT number	NCT01366703
Study type	Observational
Source	Kennemer Gasthuis
Contact	raymond tukkie, MD PhD
Phone	+31 23 5453545
Email	tukkie@kg.nl
Status	Recruiting
Phase	N/A
Start date	May 2011
Completion date	December 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Optimized Heart Failure Therapy Through Continuous Monitoring — pharao

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms