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| Sponsor: | Kennemer Gasthuis |
|---|---|
| Collaborator: |
Medtronic |
| Information provided by (Responsible Party): | Dr. R. Tukkie MD PhD FESC, Kennemer Gasthuis |
| ClinicalTrials.gov Identifier: | NCT01366703 |
Purpose
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
Secondary study parameters/outcome of the study
| Condition | Intervention |
|---|---|
|
Heart Failure |
Device: implantable loop recorder Medtronic reveal XT Full view |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study |
Primary study parameters/outcome of the study:
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: Medtronic reveal XT Full view
|
no additional description needed
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
50 patients with stable heart failure
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: raymond tukkie, MD PhD | +31 23 5453545 | tukkie@kg.nl |
| Contact: Robert Tieleman, MD PhD | +31 50 5245245 | r.tieleman@mzh.nl |
| Netherlands | |
| Rijnstate ziekenhuis | Recruiting |
| Arnhem, Netherlands | |
| Contact: hans bosker, MD PhD hbosker@alysis.nl | |
| Deventer Ziekenhuis | Recruiting |
| Deventer, Netherlands | |
| Contact: Ype Tuininga, MD PhD y.s.tuininga@dz.nl | |
| Martini Ziekenhuis | Not yet recruiting |
| Groningen, Netherlands | |
| Contact: Robert Tieleman, MD PhD r.tieleman@mzh.nl | |
| Kennemer gasthuis | Recruiting |
| Haarlem, Netherlands, 2000 AK | |
| Contact: raymond tukkie, MD PhD +31 23 5453545 tukkie@kg.nl | |
| Contact: Bob van Vlies, MD PhD +31 23 5453545 vlies@kg.nl | |
| Principal Investigator: raymond tukkie, MD PhD | |
| Rijnland Ziekenhuis | Recruiting |
| Leiderdorp, Netherlands | |
| Contact: Charles Kirchhof, MD PhD ch.kirchhof@orange.nl | |
| Principal Investigator: | raymond tukkie, MD PhD | Kennemer Gasthuis |
More Information
| Responsible Party: | Dr. R. Tukkie MD PhD FESC, Dr., Kennemer Gasthuis |
| ClinicalTrials.gov Identifier: | NCT01366703 History of Changes |
| Other Study ID Numbers: | pharao multicentre study |
| Study First Received: | June 2, 2011 |
| Last Updated: | May 12, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
heart failure implantable loop recorder |
|
Heart Failure Heart Diseases Cardiovascular Diseases |
