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Estech to start enrollment in ATTAC-AF IDE trial
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Estech
: 10 April, 2012 (Company News) |
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Estech, a leader in minimally invasive and endoscopic cardiac ablation, receives conditional Investigational Device Exemption (IDE) approval from the the US FDA to initiate patient enrollment in the Estech-sponsored ATTAC-AF trial. |
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The IDE trial has been designed to evaluate the treatment of atrial fibrillation (AF) utiliing temperature-controlled radiofrequency (TCRF) ablation in patients undergoing cardiac surgery. Up to 15 centres in the United States and Europe will participate in the trial, which is intended to enroll over 100 cardiac surgery patients.
The ATTAC-AF trial will enroll cardiac surgery patients who have a history of non-paroxysmal AF. During the cardiac surgical procedure for treatment of coronary or valve disease, patients will also be treated for their atrial fibrillation disease with Estech's COBRA Ablation probes utilising patented TCRF technology. Patients enrolled in the ATTAC-AF trial will be followed for a minimum of one year to determine the success rate for preventing recurrence of AF and to assess the patient’s quality of life following the ablation procedure.
For patients referred for cardiac surgery, non-paroxysmal atrial fibrillation is exceptionally important because its associated morbidity causes significantly poorer survival rates compared to patients with normal sinus rhythm (NSR). Approximately, 30 to 40 percent of patients undergoing mitral valve repair have pre-existing non-paroxysmal AF. Patients in NSR following mitral valve operation have increased one and four year survival rates compared with those in AF. The increased rates of morbidity and mortality associated with patients who remain in AF after surgery demonstrate the need for an effective and reliable treatment for AF.
"This is a very important study to get the indication to treat atrial fibrillation surgically," said the principal investigator Niv Ad, MD, Chief of Cardiac Surgery and Director of Cardiac Surgery Research at Inova Heart and Vascular Institute, Virginia, USA. "I have found Estech's temperature-controlled RF technology to be of very high quality and Estech employees to be dedicated and committed to excellence in cardiac ablation," Dr Ad continued. "With the anticipated participation of some of the best cardiac surgery centers in the USA and Europe, this promises to be an excellent study." |
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