Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 8:41 AM
Study NCT ID:
NCT01366703
Status:
UNKNOWN
Last Update Posted:
2012-05-15
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Heart Failure Therapy Through Continuous Monitoring
Sponsor:
Kennemer Gasthuis
Organization:
Study Overview
Official Title:
Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pharao
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.
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.
Detailed Description:
no additional description needed
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: