Optimized Heart Failure Therapy Through Continuous Monitoring

NCT01366703 | Unknown DMC

• 1 other identifier: pharao multicentre study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure

Keywords

heart failure; implantable loop recorder

Outcome Measures

Primary Outcomes (1)

• registered arrhythmias with implantable loop recorder during follow-up period

  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 Outcomes (1)

• prediction of worsening heart failure through cardiac compass

  during follow-up (1 year after last included patient)

Study Arms (1)

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

Interventions

implantable loop recorder Medtronic reveal XT Full view DEVICE

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

Also known as: Medtronic reveal XT Full view

heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 patients with stable heart failure

You may qualify if:

• EF \> 35%
• NYHA 2-3
• No AF documented
• Not on OAC

You may not qualify if:

• use of OAC
• documented AF \> 30 sec
• planned or actual PM/ICD
• life-expectancy \< 1 year
• no informed consent

Sponsors & Collaborators

• Kennemer Gasthuis: lead
• Medtronic: collaborator

Study Sites (5)

Rijnstate ziekenhuis

Arnhem, Netherlands

RECRUITING

Deventer Ziekenhuis

Deventer, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, Netherlands

NOT YET RECRUITING

Kennemer gasthuis

Haarlem, 2000 AK, Netherlands

RECRUITING

Rijnland Ziekenhuis

Leiderdorp, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• raymond tukkie, MD PhD

  Kennemer Gasthuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

raymond tukkie, MD PhD

CONTACT

+31 23 5453545; tukkie@kg.nl

Robert Tieleman, MD PhD

CONTACT

+31 50 5245245; r.tieleman@mzh.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

NL (5)