Optimized Heart Failure Therapy Through Continuous Monitoring (pharao)

May 12, 2012 updated by: Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

no additional description needed

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate Ziekenhuis
        • Contact:
      • Deventer, Netherlands
      • Groningen, Netherlands
        • Not yet recruiting
        • Martini Ziekenhuis
        • Contact:
      • Haarlem, Netherlands, 2000 AK
        • Recruiting
        • Kennemer Gasthuis
        • Contact:
          • raymond tukkie, MD PhD
          • Phone Number: +31 23 5453545
          • Email: tukkie@kg.nl
        • Contact:
          • Bob van Vlies, MD PhD
          • Phone Number: +31 23 5453545
          • Email: vlies@kg.nl
        • Principal Investigator:
          • raymond tukkie, MD PhD
      • Leiderdorp, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 patients with stable heart failure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Medtronic reveal XT Full view

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year follow-up after last included patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during follow-up (1 year after last included patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kennemer Gasthuis

Collaborators

Medtronic

Investigators

  • Principal Investigator: raymond tukkie, MD PhD, Kennemer Gasthuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 12, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pharao multicentre study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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