Optimized Heart Failure Therapy Through Continuous Monitoring

Heart Failure Clinical Trial

— pharao  

Official title:

Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01366703
• Other study ID #: pharao multicentre study
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2011
• Last updated: May 12, 2012
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Kennemer Gasthuis
• Contact: raymond tukkie, MD PhD
• Phone: +31 23 5453545
• Email: tukkie[@]kg.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Description:

no additional description needed

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Netherlands	Rijnstate ziekenhuis	Arnhem
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Kennemer gasthuis	Haarlem
Netherlands	Rijnland Ziekenhuis	Leiderdorp

Sponsors (2)

Lead Sponsor	Collaborator
Kennemer Gasthuis	Medtronic

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	prediction of worsening heart failure through cardiac compass	Predective value of the cardiac Compass data to predict worsening heart failure episodes.	during follow-up (1 year after last included patient)	No