Optimized Heart Failure Therapy Through Continuous Monito... | NCT01366703

NCT01366703

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Medtronic	INDUSTRY

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
raymond tukkie, MD PhD	Contact	+31 23 5453545		tukkie@kg.nl
Robert Tieleman, MD PhD	Contact	+31 50 5245245		r.tieleman@mzh.nl

Name	Affiliation	Role
raymond tukkie, MD PhD	Kennemer Gasthuis	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Rijnstate ziekenhuis	Recruiting	Arnhem			Netherlands

Condition Browse Module

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases