Optimized Heart Failure Therapy Through Continuous Monitoring
NCT ID: NCT01366703
Last Updated: 2012-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2011-05-31
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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heart failure patients
stable heart failure patients, NYHA 1-2, EF \> 35%, no AF, No OAC, CHADS score \>2
implantable loop recorder Medtronic reveal XT Full view
Medtronic Reveal implantable loop recorder with home-monitoring using carelink will be implanted in every patient and used to continuously monitor the patients during follow-up to detect symptomatic and asymptomatic arrythmias during follow-up
Interventions
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implantable loop recorder Medtronic reveal XT Full view
Medtronic Reveal implantable loop recorder with home-monitoring using carelink will be implanted in every patient and used to continuously monitor the patients during follow-up to detect symptomatic and asymptomatic arrythmias during follow-up
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NYHA 2-3
* No AF documented
* Not on OAC
Exclusion Criteria
* documented AF \> 30 sec
* planned or actual PM/ICD
* life-expectancy \< 1 year
* no informed consent
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Kennemer Gasthuis
OTHER
Responsible Party
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Dr. R. Tukkie MD PhD FESC
Dr.
Principal Investigators
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raymond tukkie, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Kennemer Gasthuis
Locations
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Rijnstate ziekenhuis
Arnhem, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Kennemer gasthuis
Haarlem, , Netherlands
Rijnland Ziekenhuis
Leiderdorp, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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pharao multicentre study
Identifier Type: -
Identifier Source: org_study_id
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