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Optimized Heart Failure Therapy Through Continuous Monitoring (pharao)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Kennemer Gasthuis.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis
ClinicalTrials.gov Identifier:
NCT01366703
First received: June 2, 2011
Last updated: May 12, 2012
Last verified: May 2012
  Purpose

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 Intervention
Heart Failure
Device: implantable loop recorder Medtronic reveal XT Full view

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study

Resource links provided by NLM:


Further study details as provided by Kennemer Gasthuis:

Primary Outcome Measures:
  • 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:

    • 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:
  • 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.


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

no additional description needed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 2, 2011
Last Updated: May 12, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Kennemer Gasthuis:
heart failure
implantable loop recorder

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014