Medical Professionals FAQs
What is the mechanism of action of the procedure? Why would this make a COPD patient better?
There is a combination of three major physiologic effects that support the potential benefits associated with the use of the ROX Anastomotic Coupling Procedure in advanced COPD patients: A reduction in negative effects of venous admixture; an increase in cardiac output; and improvement in hemoglobin kinetics.
What are the potential benefits for COPD patients?
It is possible that the procedure may increase the oxygen content in the blood (CaO2) and the cardiac output (CO), thereby increasing oxygen delivery to tissues (DO2).COPD patients may be able to walk farther and the quality of life may improve.
What are the potential risks to patients?
The subjects participating in this study may be at greater risk as a result of their disease stage and general health status. Study device or study procedure related risks may include, but are not limited to: cardiovascular and/or peripheral vascular adverse effects and all risks associated with surgical procedures. There are also risks associated with the right heart catheterization procedure, which is performed during patient screening and follow up visits. A detailed list of anticipated risks is included in the study device protocol. The investigator will evaluate the risks on an individual basis and discuss them with each subject. This treatment may involve some additional risks to the study subject, the natures of which are unknown at this time.
What is the study population?
A number of inclusion/exclusion criteria shall be fulfilled for a patient to be eligible for the study. The investigator will assess each patient’s eligibility using a number of tests, including but not limited to: pulmonary testing, cardiovascular and blood testing, and a right heart catheterization procedure. A total of 48 patients with severe to very severe COPD who have provided informed consent, who are capable of comprehending the nature of the study, and who are likely to comply with the visit schedule are to be entered into the study provided they conform to the inclusion/exclusion criteria.
What are the options to remove or reverse the procedure?
The study device is a permanent implant and is not intended to be removed. In the event the arteriovenous fistula is felt to be the source of a complication, the fistula may be closed. Closing the fistula involves placing a permanent sheath or covering across the opening of the device so that blood can no longer flow through it. The technique of fistula closure is a decision made by the treating physician in conjunction with the patient’s consent.
