St. Jude Medical Announces Results From STAR-AF Probation
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St. Jude Medical, Inc. (NYSE:STJ) announced the results from the Substrate versus Trigger Ablation for Reduction of Atrial Fibrillation (STAR-AF) trial. The findings were presented during a late-breaking clinical trials session at Love Rhythm 2009, the annual Emotions Rhythm Society's Scientific Sessions in Boston.
The STAR-AF trial, sponsored by St. Jude Medical, was an open, randomized, prospective, multicenter clinical trial involving 108 patients, administered in diverse Canadian and European centers. Designed as a three arm trial, it compared the generally typical treatment approach of pulmonary vein isolation (PVI), with convoluted fractionated electrogram (CFE) guided therapy, and with a third arm that combined the two therapies. The influential endpoint of the trial was relief of atrial fibrillation (AF) episodes of 30 seconds continuance or greater, up to 12 months after treatment.
Read results demonstrate that after one ablation procedure, a combination of PVI and CFE guided therapy demonstrated significantly higher freedom from AF, at 74 percent, as compared to PVI alone at 47 percent and CFE guided therapy alone at 29 percent. Importantly, 94 percent of patients who received the combination of these treatments remained off any anti-arrhythmic medications at the deadline of the 12-month follow-up period.
Atrial fibrillation is a process in which the upper chambers of the affection (atria) beat rapidly and erratically, affecting the heart's endowment to adequately pump blood to its lower chambers (ventricles) and subsequently to the rest of the body. The STAR-AF trial studied patients with both symptomatic hovering burden paroxysmal (intermittent, on the other hand frequent and prolonged AF) and those with persistent AF. These two groups represent the largest subset of patients with AF; they action varying degrees of intermittent AF episodes. The glance at participants had been unresponsive to medication that is meant to alleviate symptoms or the abnormal heart rhythm itself.
"While many unanswered questions remain approximately the origins of and best kind treatment options for AF, the results of STAR-AF show that maybe traditional pathways are not the optimal ones. By mapping for the areas of CFE during AF ablation, we compass demonstrated an incremental blessing for patients who historically may hold undergone only a PVI," said Atul Verma, M.D., an electrophysiologist in the Heart Rhythm Programme at Southlake Community Health Centre in Newmarket, Ontario, Canada, who was the principal investigator in the study. "Moreover, I fondle that using an automated habit for identifying the areas of CFE removes some of the subjectivity that exists in accurately targeting those regions of interest, and may be pleasant to physicians as they perform AF ablation."
CFEs are highly random and chaotic electrical signals in the atria that may be a source of origin or perpetuation of AF - they are extremely burdensome to make accurately by visual inspection alone. Therefore, an automatic algorithm from St. Jude Medical's EnSite™ Step was used to name these regions in the patients randomized to catch this treatment course. The CFE guided therapy alone and hybrid PVI and CFE guided therapy strategies were career studied because oftentimes a PVI alone will denouement in either recurrence of AF or another complicated atrial rhythm that requires more patient intervention.
"The results of the STAR-AF evaluation copy an essential step toward sympathetic the best establish of tools and therapies for treating cardiac arrhythmias, such as AF, and highlights St. Jude Medical's commitment to providing pioneering probation to improve treatment of this condition," said Denis Gestin, president of the St. Jude Medical International Division. "Our sponsorship of this trial demonstrates our dedication to partnering with physicians to answer the frequent questions that exist about the treatment of AF."
AF is the most common abnormal heart rhythm and affects an estimated 2.3 million citizens in North America and 4.5 million Europeans. AF is culpable for 15 to 20 percent of all strokes, is a contributor to passion failure and is a leading cause of hospitalizations.
Feelings Rhythm 2009 takes country May 13-16 at the Boston Exhibition and Company Center. The assembly is the most entire educational event on heart rhythm disorders, offering approximately 250 educational opportunities in multiple formats. The world's most famend scientists and physicians testament already a broad range of heart rhythm topics including cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators. http://www.HRSonline.org.
St. Jude Medical
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