Sorin Group initiates multi-centre study of heart failure patients in
Europe
22 June 2006 Paris, France. Sorin Group Cardiac Rhythm Management (CRM)
Business Unit, has announced the first patient enrolments in Germany and
Portugal in a study of the clinical relevance of slow ventricular
tachycardias (VTs) in a heart failure population. Called the BITAC
(biventricular tachycardias outcome in CRT-D patients) clinical study, the
purpose is to assess the incidence of slow ventricular tachycardias (VTs) in
heart failure patients implanted with CRT-D devices, as well as the clinical
relevance of treating slow VTs during a 2-year follow-up period. The
principal investigator for the study is Dr. Alexander Bauer, University
Hospital of Heidelberg, Germany. Sub-analysis of studies performed in a
general implantable cardioverter defibrillator (ICD) population has shown
that slow VTs (<150 beats per minute) are more prevalent and have more
serious consequences in those patients with depressed ventricular function.(1)
The BITAC study specifically aims to address the clinical relevance of slow
VTs in a heart failure population and to offer physicians better insight on
how to improve the management of ventricular arrhythmias in CRT-D patients.
Patients included in the multicenter BITAC study have advanced heart failure
and are at increased risk of sudden cardiac death (SCD), a condition in
which the heart stops suddenly and unexpectedly.
Heart failure, an inability of the heart to pump enough blood to meet the
body's needs, affects 10 million Europeans.(2) Cardiac
resynchronization therapy (CRT) devices deliver pacing impulses to the heart
muscle to resynchronize the contractions of the ventricles and thus increase
cardiac pump efficiency. As heart failure patients are up to 9 times more
likely to suffer SCD than the general population(3),
combining CRT with an implantable defibrillator (CRT-D) can be life-saving
for these patients. The first patients to be enrolled in the study were
implanted with Sorin Group's Ovatioä CRT, the world's smallest CRT-D. The
device includes the unique Brady Tachy Overlap (BTOä) function which allows
the setting of low-rate detection zones for slow VTs, whilst still allowing
pacing and delivery of resynchronization therapy during patient exercise.
The implants were performed at the St. Adolf-Stift Hospital in Reinbek,
Germany by Dr. Herbert Nagele, Senior Assistant Medical Director, and at the
Hospital Fernando Da Fonseca in Amadora, Portugal by Dr. Francisco Madeira,
Assistant Cardiologist and Electrophysiologist, and by Dr. Pedro Cunha,
Assistant Cardiologist, in the Pacing and Arrhythmia Unit headed by Dr.
Carlos Morais. Dr. Francisco Madeira commented: "this important study will
give physicians better insight into the management of slow VTs for heart
failure patients. It will be of particular interest because, until today,
technology limitations restricted our ability to monitor and treat slow VTs
in HF patients without compromising the delivery of cardiac
resynchronization therapy".
Andre-Michel Ballester, President of Sorin Group Cardiac Rhythm
Management (CRM) Business Unit commented that "this study represents a
continuation of Sorin Group's efforts to bringing innovative technology to
each and every patient. Our objective is to demonstrate the ability of
Sorin's unique BTO function to monitor the effects of slow VT for heart
failure patients". The BITAC study will enroll over 400 patients across
Europe. Enrollment is anticipated to be completed by end 2007.
References
1. Sadoul N., Mletzko R., Anselme F. et al. Internal sub
analysis (375 patients) of the IDEF08 Slow VT study. Incidence and Clinical
Relevance of Slow Ventricular Tachycardia in Implantable
Cardioverter-Defibrillator Recipients: An International Multicenter
Prospective Study. Circulation
Aug 16,2005, 946-953.
2. Cleland JG, Swedberg K, Follath F et al.The EuroHeart
Failure Survey Programme- A Survey of the Quality of Care Among Patients
with Heart Failure in Europe. Part 1: Patient Characteristics and Diagnosis.
Eur Heart J 2003;24:442-463.
3. American Heart Association. Heart Disease and Stroke
Statistics. 2005 Update. Dallas, Texas: American Heart Association.
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