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Optimized Heart Failure Therapy Through Continuous Monitoring (pharao)

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ClinicalTrials.gov Identifier: NCT01366703
Recruitment Status : Unknown
Verified May 2012 by Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis.
Recruitment status was:  Recruiting
First Posted : June 6, 2011
Last Update Posted : May 15, 2012
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. R. Tukkie MD PhD FESC, 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.

Condition or disease Intervention/treatment
Heart Failure Device: implantable loop recorder Medtronic reveal XT Full view

Detailed Description:
no additional description needed

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study
Study Start Date : May 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort Intervention/treatment
heart failure patients
stable heart failure patients, NYHA 1-2, EF > 35%, no AF, No OAC, CHADS score >2
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



Primary Outcome Measures :
  1. registered arrhythmias with implantable loop recorder during follow-up period [ Time Frame: 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 :
  1. prediction of worsening heart failure through cardiac compass [ Time Frame: during follow-up (1 year after last included patient) ]
    Predective value of the cardiac Compass data to predict worsening heart failure episodes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 patients with stable heart failure
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366703


Contacts
Contact: raymond tukkie, MD PhD +31 23 5453545 tukkie@kg.nl
Contact: Robert Tieleman, MD PhD +31 50 5245245 r.tieleman@mzh.nl

Locations
Netherlands
Rijnstate ziekenhuis Recruiting
Arnhem, Netherlands
Contact: hans bosker, MD PhD       hbosker@alysis.nl   
Deventer Ziekenhuis Recruiting
Deventer, Netherlands
Contact: Ype Tuininga, MD PhD       y.s.tuininga@dz.nl   
Martini Ziekenhuis Not yet recruiting
Groningen, Netherlands
Contact: Robert Tieleman, MD PhD       r.tieleman@mzh.nl   
Kennemer gasthuis Recruiting
Haarlem, Netherlands, 2000 AK
Contact: raymond tukkie, MD PhD    +31 23 5453545    tukkie@kg.nl   
Contact: Bob van Vlies, MD PhD    +31 23 5453545    vlies@kg.nl   
Principal Investigator: raymond tukkie, MD PhD         
Rijnland Ziekenhuis Recruiting
Leiderdorp, Netherlands
Contact: Charles Kirchhof, MD PhD       ch.kirchhof@orange.nl   
Sponsors and Collaborators
Kennemer Gasthuis
Medtronic
Investigators
Principal Investigator: raymond tukkie, MD PhD Kennemer Gasthuis

Responsible Party: Dr. R. Tukkie MD PhD FESC, Dr., Kennemer Gasthuis
ClinicalTrials.gov Identifier: NCT01366703     History of Changes
Other Study ID Numbers: pharao multicentre study
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis:
heart failure
implantable loop recorder

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases