Apr 3 2012
Estech, a leader in minimally invasive and endoscopic cardiac ablation,
announced today that the Food and Drug Administration (FDA) has given
conditional Investigational Device Exemption (IDE) approval to initiate
patient enrollment in the Estech-sponsored ATTAC-AF trial. The IDE trial
has been designed to evaluate the treatment of atrial fibrillation (AF)
utilizing temperature-controlled radiofrequency (TCRF) ablation in
patients undergoing cardiac surgery. Up to 15 centers 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 utilizing 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% 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 & 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 U.S. and Europe, this
promises to be an excellent study."