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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

June 2, 2011
May 12, 2012
May 2011
December 2012   (final data collection date for primary outcome measure)
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
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

Complete list of historical versions of study NCT01366703 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Optimized Heart Failure Therapy Through Continuous Monitoring
Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study

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.

no additional description needed

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

50 patients with stable heart failure

Heart Failure
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: raymond tukkie, MD PhD +31 23 5453545 tukkie@kg.nl
Contact: Robert Tieleman, MD PhD +31 50 5245245 r.tieleman@mzh.nl
Netherlands
 
NCT01366703
pharao multicentre study
Yes
Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis
Kennemer Gasthuis
Medtronic
Principal Investigator: raymond tukkie, MD PhD Kennemer Gasthuis
Kennemer Gasthuis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP