Optimized Heart Failure Therapy Through Continuous Monitoring (pharao)
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| First Received Date ICMJE | June 2, 2011 | ||||||||
| Last Updated Date | May 12, 2012 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
registered arrhythmias with implantable loop recorder during follow-up period [ Time Frame: 1 year follow-up after last included patient ] [ Designated as safety issue: No ] Primary study parameters/outcome of the study:
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| Original Primary Outcome Measures ICMJE |
registered arrhythmias with implantable loop recorder during follow-up period [ Time Frame: 1 year follow-up after last included patient ] [ Designated as safety issue: No ] Primary study parameters/outcome of the study: Primary endpoints - AF burden en AF episodes detected - Detected other relevant arrhythmia'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 |
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| Change History | Complete list of historical versions of study NCT01366703 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
prediction of worsening heart failure through cardiac compass [ Time Frame: during follow-up (1 year after last included patient) ] [ Designated as safety issue: No ] Predective value of the cardiac Compass data to predict worsening heart failure episodes. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Optimized Heart Failure Therapy Through Continuous Monitoring | ||||||||
| Official Title ICMJE | Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study | ||||||||
| 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
Secondary study parameters/outcome of the study
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| Detailed Description | no additional description needed |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 50 patients with stable heart failure |
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| Condition ICMJE | Heart Failure | ||||||||
| Intervention ICMJE | Device: 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 Name: Medtronic reveal XT Full view |
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| Study Group/Cohort (s) | heart failure patients
stable heart failure patients, NYHA 1-2, EF > 35%, no AF, No OAC, CHADS score >2
Intervention: Device: implantable loop recorder Medtronic reveal XT Full view |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01366703 | ||||||||
| Other Study ID Numbers ICMJE | pharao multicentre study | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis | ||||||||
| Study Sponsor ICMJE | Kennemer Gasthuis | ||||||||
| Collaborators ICMJE | Medtronic | ||||||||
| Investigators ICMJE |
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| Information Provided By | Kennemer Gasthuis | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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