The Carle Heart and Vascular Institute is one of the largest cardiovascular institutes in Illinois. Our cardiologists, cardiac surgeons, vascular surgeons and interventional radiologists treat more than 30,000 patients in Illinois, Indiana and the region each year. They offer unparalleled experience in caring for patients with heart and blood vessel diseases.
What does that mean to you as a patient? It means you’ll have access to the area’s largest and most specialized care providers in the state. It means you don’t have to travel to far destinations to receive excellent care.
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Research is a core mission of Carle Heart and Vascular Institute (HVI). HVI works closely with the Stephen’s Family Clinical Research Institute to offer patients leading-edge therapies through clinical trials. Our physician investigators (cardiologists, cardiac surgeons, vascular surgeons and radiologists) are involved in multiple national and investigator-initiated studies that span the field of pharmacotherapy and interventional devices. Also, HVI is actively involved in translational research activities in collaboration with the Beckman Institute for Advanced Science and Technology.
The Cryo AF Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to evaluate and describe clinical performance and safety data in a broad patient population treated with a commercially available Arctic Front™ Family of Cardiac Cryoablation Catheters (hereafter referred to as "Arctic Front™ Cardiac Cryoablation Catheter System"). The cryoballoon ablation(CBA) procedure will be performed according to routine hospital practice. The study is expected to have a 24 month enrollment period. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
The purpose of this registry (“the PERT Registry”) is to gather data on patients diagnosed with pulmonary embolism, treated by the Pulmonary Embolism Response Team (PERT) at each site and beyond for epidemiologic, therapeutic, quality assessment and outcomes research.
A total of 352 subjects will be randomized at up to 75 investigational sites in the United States, Canada, Europe and Australia. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio. Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation as well as a review by a Central Review Committee to determine appropriateness for the implant procedure. On the day of the procedure, a coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the CARILLON implant. If the subject meets the anatomic requirements for device placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control). Subjects randomized to the Intervention group will undergo the CARILLON implant procedure. With the distal aspect of the device anchored, incremental tension will be applied to plicate the peri-annular tissue. After the proximal anchor of the implant is locked in place, safety and efficacy will be reconfirmed prior to releasing the CARILLON implant from the delivery system. Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without device placement) to ensure that they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure. After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status. After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact for an additional three (3) years, for a total of five (5) years. Any additional therapies which are required to treat symptomatic or advancing disease subjects will be reviewed by a Central Review Committee for endpoint evaluation as long as the subject was treated >6months after randomization so that all subjects may remain on the trial for the entire 5 years of follow up.
With doctors practicing in 80 specialties at locations throughout the region, it’s easy to find the right healthcare team at Carle. Our mission is to serve people through high quality care, medical research and education.
Recognized among the nation’s top hospitals, Carle provides excellent healthcare while continuously improving to meet the needs of our patients.