ZERO AF Study Patient Information
ZERO AF is an acronym formed from the letters in the Clinical Study title: The Clinical Evaluation of the Blazer® Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.
Please ask your study doctor or healthcare professional to answer your questions or explain anything that is not clear to you, or if there are any words you do not recognize or understand.
Overview of the ZERO AF Clinical Study
This study is a randomized, controlled study in which half of the patients will receive cardiac ablation with the investigational device, Blazer Open-Irrigated Ablation Catheter and half of the patients with the control device, Thermocool® Cardiac Ablation Catheter, from Biosense Webster, a product approved for the treatment of paroxysmal atrial fibrillation.
The purpose of this study is to evaluate the safety, performance and effectiveness (success) of a new ablation catheter used to treat atrial fibrillation. All participants will continue to receive Standard Medical Care and will be followed by the study staff for 12 months.
The purpose of this study is to evaluate the safety, performance and effectiveness (success) of a new ablation catheter used to treat atrial fibrillation. All participants will continue to receive Standard Medical Care and will be followed by the study staff for 12 months. Your assignment to the Investigational or Control group will be made at random, using a computer-generated list. Neither you nor your Study Doctor will be able to choose your group.
Up to 472 patients will participate in this study. The study will be conducted in over 33 medical centers in the US, Europe, Australia and Asia. A portion (100) of the study participants will also be included in a pulmonary vein imaging sub-study.
The purpose of the imaging sub-study is to look at the size of the blood vessels in the left upper chamber of your heart before and after the ablation procedure.
About the Investigational Device
The Blazer Open-Irrigated Catheter is a thin, flexible plastic tube that uses radiofrequency energy (electrical energy) to stop abnormal heart rhythms in the heart. The Blazer Open-Irrigated Catheter is one of the latest additions to Boston Scientific’s portfolio of ablation catheters.* It was approved for use in Europe, Canada, and other countries in 2010. The Blazer Open-Irrigated Catheter offers the Total Tip Cooling™ design, engineered to consistently cool the entire tip of the electrode during radiofrequency energy delivery.
*The device is considered investigational in the United States and is only available for investigational use.
About the Study Sponsor
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, Boston Scientific advances science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, please visit www.bostonscientific.eu.