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Hypertension, or high blood pressure, is a medical condition in which constricted arterial blood vessels increase the resistance to blood flow, causing blood to exert excessive pressure against the walls of a person's arteries. This causes the heart to work harder to pump blood through the narrowed arteries and can lead to long term damage to the heart and blood vessels.
Hypertension affects over 72 million people in the United States and is estimated to cause one in every eight deaths worldwide. Each increase in 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes. It is a costly disease and yearly costs to treat hypertension in the United States are estimated to be $69.4 billion. Approximately 25 percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications. It is a disease that needs new treatment solutions.
The human body has its own physiologic mechanisms of sensing changes in blood pressure and controlling blood pressure. The major part of this system is located in the brain and also in the walls of the carotid arteries, located in the neck. Pressure sensors called baroreceptors are located on the carotid artery. These sensors measure and report blood pressure to the brain, where it is compared to the needs of the body. For example, higher blood pressure is good for exercising, while lower blood pressure is appropriate during sleep or other periods of reduced activity. If the brain senses higher-than-needed blood pressure from the baroreceptors, it acts to lower high blood pressure by sending signals to various parts of the body to lower blood pressure, including the heart, blood vessels and kidneys.
“Baroreflex” or “baroreceptor reflex” are terms used to describe the body's rapid response system for dealing with changes in blood pressure.
The Rheos High Blood Pressure Treatment System also known as Rheos® HT Baroreflex Hypertension Therapy™ System is designed to reduce blood pressure by using mild electrical signals to influence the body’s blood pressure regulation system, called the baroreflex. The device has 3 parts: a battery powered pack (pulse generator) that is surgically placed (implanted) under the skin near the collarbone and 2 wires (leads) that go under the skin from the battery powered pack to the left and right arteries in your neck. The leads are wrapped around the carotid arteries, which is where the baroreceptors are located. The pulse generator delivers energy through the leads to activate the baroreceptors, which then sends signals to the brain to reduce high blood pressure. It is considered a fundamentally new potential approach for hypertension treatment.
CVRx, Inc. is sponsoring the Rheos Hypertension Pivotal Trial. This clinical trial for an alternative hypertension treatment will evaluate the safety and effectiveness of the Rheos High Blood Pressure Treatment System® Baroreflex Hypertension Therapy™ System. Up to 50 clinical sites will be involved in the study and 300 patients are being enrolled. Patients that have high blood pressure that cannot be controlled with medications and lifestyle changes are potential candidates for the study. For more study information go to www.cvrx.com.
It is possible that you could initially be accepted for admission to the study, but not receive the device. This would happen if your doctor determined during the screening process or implantation surgery that the device is not right for you. If this were to happen, you would not be allowed to take part in the study.
For the first month, all participants who receive the device will have it turned off. After the first month, participants will be randomized into two groups: one group will have the device turned on and the other group will not. Participants will not know which group they are in. After six months, all devices will be turned on and all participants will be followed for another six months.
You will not be charged for the Rheos High Blood Pressure Treatment high blood pressure controlling System or for tests related to the study. Your insurance company or Medicare (if applicable) will be billed for the doctor visits, hospitalization, tests and implantation surgery. CVRx will reimburse the medical center and/or doctors its fair costs for the medical tests and procedures required for the study if they are not covered by your insurance company or Medicare (if applicable). However, you may be responsible for any co-payments and deductibles that are standard for your insurance company.
All patients who participate in this study are required to review an informed consent document with the doctors and/or nurses involved in the study. The informed consent document describes the study, including its purpose, duration, required procedures, risks and potential benefits. You should carefully review this document and make you have all of your questions answered. All patients who wish to be in the study must sign the informed consent document.
After signing the informed consent document, you will undergo screening tests to determine if you qualify for the research study. If you qualify, you will have a surgical procedure to implant the device. Study participants will be required to make an office visit 1, 2, 3, 6, 7, 8, 9, 12 and 13 months after surgery. At each of these office visits, you will be asked questions about your health and undergo various standard tests (such as urine and blood tests, taking your blood pressure or having an ultrasound). In between visits, participants will also be asked to occasionally wear a blood pressure cuff for 24-hours to take blood pressure measurements throughout the day.
After the visit at 13 months, all patients will be asked to return for doctor visits once every 3 months for up to 5 years after surgery.
You will be in the hospital for a short stay and then scheduled for follow-up doctor visits. Approximately one month after surgery your doctor will either program your treatment schedule into your Rheos High Blood Pressure Treatment or Hypertension Treatment System or have it remain off. You will be followed for six months. At the end of seven months, all patients will have their device turned on; and patients will be followed for an additional six months. Every time you visit your doctor, the device will be checked. When the device is on, it works automatically and continuously.
This trial will evaluate the safety and effectiveness of this new investigational treatment for hypertension. Early clinical results have shown positive results (see home page for details). But, there are no guarantees and it is not known what the therapy response will be for each patient.
Every person has different healing and scarring results and you should expect some scarring from the surgery. If this a special concern for you, discuss it with your study doctor.
If you have a small frame or are thin it is likely that the device will be noticeable as a slight bulge below your collarbone. The leads should not be noticeable under your skin.
As with any medical device and/or procedure, there are serious and even life-threatening risks and side effects that can occur. The risks of the Rheos High Blood Pressure controlling System are listed in the informed consent document that potential patients review before participating in this study. You should discuss this with your doctor and make sure you understand the potential risks and benefits of the Rheos High Blood Pressure Treatment System before you agree to be in this study. If you are accepted into the study, your doctor will inform you of significant new findings that may affect your willingness to continue participation.
We are only able to tell you if you’ve met the initial screening eligibility criteria. All final decisions regarding eligibility to participate in the clinical study are made by the study physician.
Please review the CVRx Privacy Policy for more information about how CVRx will protect the privacy of the information you share via this website. The informed consent document describes how any personal information shared during the study will be protected.
The United States government and, specifically, the Food and Drug Administration (FDA) have strict regulations and safeguards in place to protect people who choose to participate in clinical trials. Additionally, every clinical trial in the U.S. must be reviewed and approved by an Institutional Review Board (IRB). The purpose of an IRB is to protect the rights and safety of people who volunteer to take part in research studies. Before participating in a trial, a person must agree to sign an informed consent form, which provides detailed information about the study and study procedures. Experienced doctors who have been thoroughly trained are designated as investigators for the study. These investigators (doctors), who specialize in a specific condition or disease, administer the study procedures and closely monitor study participants. For more information on clinical research trials, visit ClinicalTrials.gov. If you have additional questions, please call 1 (888) 8BP-Risk or 1 (888) 827-7475.
The clinical study discussed above is an investigation
permitted by the Food and Drug Administration. The information provided
is purely informational and not all-inclusive. The full terms of the investigation
are detailed and are disclosed in the patient consent form and by the
physician.
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