Berlin, January 21st, 2008. BIOTRONIK today announced the enrollment of the first patient into the CASTLE-AF study (Catheter Ablation versus Standard conventional Treatment in patients with LEft ventricular dysfunction and Atrial Fibrillation). The CASTLE-AF landmark trial is designed to investigate the clinical effect of ablation of atrial fibrillation (AF) versus conventional therapy on mortality and morbidity in patients suffering from heart failure.
Atrial Fibrillation - Implications and Therapeutic Approaches
Atrial fibrillation (AF) is a growing cardiac rhythm disease with an increased incidence in older populations. This disease currently affects 2.2 million people in the USA and 4.5 million in Europe. From the age of 50, the risk of acquiring AF doubles with every decade of life. The presence of AF greatly increases the risk of embolic strokes, reduces life expectancy and can have a severe impact on a patient’s quality of life. Heart failure (HF) patients are particularly prone to suffer from the deleterious effects of atrial fibrillation, since reduced atrial performance further compromises these patients’ already impaired cardiac output. Clinical data shows that these patients benefit from a restoration of normal sinus rhythm.
AF is often triggered by focal sources, located within the pulmonary veins and their antra. It has been demonstrated that electrical isolation of these triggers by performing a radiofrequency based isolation of PVs can lead to a curative AF-treatment in a significant number of patients suffering from this arrhythmia. Since the initiation of this treatment modality it has emerged as a reasonable alternative to pharmacological therapy, supported by ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. However, prospective data regarding long-term effects of AF ablation strategy on mortality and morbidity in patients with heart failure is still lacking.
CASTLE-AF and the concept of evidence based medicine
The CASTLE-AF trial compares the effectiveness of ablation procedure to conventional therapy in patients with atrial fibrillation, heart failure and an indication for an implantable cardioverter defibrillator (ICD). This is the first time that such a trial has focused on mortality and morbidity as the composite primary endpoint in this patient population. As the world‘s largest randomized clinical study of its kind, CASTLE-AF will be carried out with 420 patients in 9 countries worldwide. Secondary trial endpoints include among others the occurrence of strokes, all cause hospitalization and recurrence of atrial fibrillation after ablation.
“Until now it is unclear whether ablation therapy is superior to conventional treatment in patients with heart failure and atrial fibrillation. CASTLE-AF will answer these open questions regarding the optimal treatment of this patient population” says Prof. Johannes Brachmann, member of the Executive Committee, from Klinikum Coburg, Germany. “As a landmark study, CASTLE-AF has the potential to change guidelines and clinical practice according to the concepts of evidence based medicine” adds Dr. Nassir F. Marrouche, member of the Executive Committee and study initiator from the University of Utah Health Science Center, USA.
BIOTRONIK Home Monitoring: Medical and Information Technology
All CASTLE-AF patients will receive a dual chamber ICD equipped with the BIOTRONIK Home Monitoring capability for the continuous daily monitoring of therapy outcomes during the course of the trial. BIOTRONIK is the first device company to offer Home Monitoring for its ICDs and pacemakers in the daily remote telemonitoring of patients post-implant. Since its introduction 7 years ago, this combination of medical and information technology has improved the standard of care for many cardiac device patients. The physician has ready access to important clinical information through a protected website and receives automatic and immediate alerts for unusual rhythm disturbances. If deemed medically necessary, then, the physician can request that the patient quickly returns to the clinic for more detailed follow-up.
Introducing Home Monitoring into the management of the AF patients suffering from heart failure, the CASTLE–AF patient population, improves the management of high risk patients, and on the other hand expands the treatment strategies available for the physicians. By continuously monitoring the patient’s cardiac rhythm on a daily basis, the physician can early detect occurrence of AF, both symptomatic and asymptomatic AF. As a result, an earlier intervention can be realized to suppress progression of the arrhythmia and avoid associated complications like stroke and heart failure.
BIOTRONIK – Excellence for Life
“The launch of this important study is a logical extension of BIOTRONIK’s continuous innovative approaches to improved cardiac healthcare. ‘Excellence for Life’ means helping patients and physicians to manage all aspects of cardiac rhythm disease. The CASTLE-AF trial further demonstrates our commitment to comprehensive patient care, including cardiac ablation, heart failure therapy and automated remote Home Monitoring” emphasizes Marlou Janssen, Vice President of Marketing and Sales for Cardiac Rhythm Management at BIOTRONIK GmbH & Co. KG.
About BIOTRONIK GmbH & Co. KG
As one of the worlds leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be they cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy management. Quality, innovation, and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.