Frequently Asked Questions
What is heart failure and what are the main symptoms?
Why does heart failure happen?
Can medications help when the heart does not fill properly?
How is the Rheos system designed to work?
Why do some doctors think the Rheos System may be effective for heart failure?
What are the possible benefits of participating in this clinical trial?
What are the potential risks of participating in this clinical trial?
How will I know if I can participate?
What is the purpose of this clinical trial?
What type of clinical trial is this?
Is there a placebo group in this clinical trial?
If I am accepted into this clinical trial, will I receive the Rheos® System?
If I participate, what will happen?
How often do I have to go to the clinical trial medical site for follow –up visits?
Are there costs for participating in the clinical trial?
The closest center to me is far away. Will I be paid for my travel expenses?
How will my medical information be kept confidential?
Can I withdraw from the clinical trial?
At the end of the clinical trial is the system removed?
What laboratory or other diagnostic tests or assessments are required?
How long will I be in the hospital after surgery?
What side of the body is the system implanted on?
Will the system and leads be noticeable under my skin?
Is it ok to be around microwave ovens?
Can I go on airplanes? How do I go through the airport?
Can I still be active? What activities are ok?
Does this system help or hinder erectile dysfunction or sexual activity?
Can women who are pregnant participate in the clinical trial?
How many people have been implanted with the Rheos® System so far?
How many other clinical trials have been done with the Rheos® System?
Can I follow up with a center different from the one I am implanted at?
What is the length of the battery life of the system?
Can the settings of the system be changed without surgery?
What happens at the end of the trial?
How long until the Rheos® System is approved by the U.S. Food and Drug Administration?
What are the results of high blood pressure studies to date?
Who is the clinical trial sponsor?
What is heart failure and what are the main symptoms?
Heart failure is a condition where the heart cannot pump enough blood to meet the body’s needs.
Heart failure can change a person’s life. Symptoms, medicines and hospital stays can make life difficult. This lowers the quality of a person’s life. Heart failure can get worse with time. Without effective treatment, most people with heart failure die within five years of being diagnosed.1
The main symptoms of heart failure are:
- General fatigue or weakness
- Shortness of breath
- Swelling in the legs and ankles
1. Douglas S. Lee, Philmon Gona, et al. Pathogenesis and Risk Factors to Heart Failure with Preserved or Reduced Ejection Fraction. Circulation. 2009; 119; 3070-3077
Why does heart failure happen?
The heart is a muscle that pumps oxygen-rich blood to the body. The heart pumps blood in two phases. In the first phase, it relaxes and fills with blood. In the second phase, it squeezes and pumps blood out. Heart failure happens when the heart is not able to fill or pump well enough to meet the body’s needs.
One condition that may lead to heart failure is high blood pressure. High blood pressure makes the heart work harder to pump blood out to the body. Like any muscle that is overworked, the heart becomes thick and stiff. A thick and stiff heart cannot fill properly. Heart failure that is caused by filling problems is called diastolic heart failure.
Think about how much harder it is to fill up a car tire than it is to inflate a balloon. A car tire requires high pressures to fill because it is thick and rigid. It is the same with a thick and stiff heart. A thick, stiff heart causes blood pressure in the lungs to go up. When this happens, fluid seeps into the lungs. This condition is called pulmonary edema. Pulmonary edema can cause serious breathing problems. High blood pressure in the lungs and heart also causes blood to pool in the legs. This is why people with heart failure often have swollen legs and ankles.
Other conditions, such as a heart attack, rob the heart of oxygen. This damages the heart muscle. The heart becomes flabby and weak. A weak heart cannot squeeze strongly. This means the heart cannot pump out enough blood to meet the body’s needs. Heart failure that is caused by pumping problems is called systolic heart failure.
Can medications help when the heart does not fill properly?
There are no proven therapies to help the heart fill properly. Medicines may help relieve symptoms in some cases, but they have not been proven to help the heart fill properly. Heart failure due to filling problems is called diastolic heart failure. It is usually caused by high blood pressure that has not been controlled.
Studies have shown that patients whose heart failure is due to filling problems have a poor quality of life. These people often have trouble breathing, and doing everyday activities like climbing stairs or walking. They are also at an increased risk of death.
What are the baroreceptors?
The baroreceptors (pronounced ba-roh-ree-sep-tors) are natural sensors in the body. They regulate blood flow. Baroreceptors detect the pressure of blood in the arteries. Then they send signals to the brain if the pressure needs to be changed. The brain then tells the heart, blood vessels and kidneys what to do.
The body responds by:
- Relaxing the arteries
- This makes it easier for blood to flow to the bod
- Slowing the heart down
- This gives the heart more time to fill with blood
- Reducing fluid in the body through the kidneys
- This lowers blood pressure and reduces the heart’s work load
How is the Rheos System designed to work?
The Rheos System sends electrical signals through very thin wires to the vessels of the neck called the carotid arteries. This is where the baroreceptors (pronounced ba-roh-ree-sep-tors) are located. (Click on What are the baroreceptors for more information.)
This trial will determine whether the Rheos System is safe. It will also see if the Rheos System can:
- Improve heart function
- Lower risk of death
- Increase quality of life
- Reduce the number of hospital stays related to heart failure
- Relieve heart failure symptoms
Why do some doctors think the Rheos System may be effective for heart failure?
The Rheos System has been studied in patients with uncontrolled high blood pressure. These patients were taking at least 3 blood pressure medicines. Even with medicine, they still had high blood pressure. Some of these patients also had early-stage heart failure. Data on the impact of the Rheos system on the heart was collected for 21 of these patients. Most of these 21 patients experienced positive results with the Rheos System, such as:
- Reduced size and thickness of the heart
- Improved heart function
- Reduced blood pressure2
* Heart size and thickness are determined using a left ventricular mass index.
Bisognano JD. JACC 2009;53(10) Suppl A, A188.
Fifty seven percent of these patients had hearts of normal size and thickness after one year with the Rheos System.
Two of the 21 patients experienced events such as: system movement, high blood pressure episodes, and surgical complications. All events were resolved.
Results from this trial were presented at the American College of Cardiology. They have also been published in scientific journals.
These results offer hope for people with of heart failure. Now a larger trial is needed to evaluate the safety and effectiveness of the Rheos System in these patients.
2. Bisognano JD, de Leeuw P, Bach DS, Kaufman CL, Eric G. Lovett, for the DEBuT-HT and Rheos Feasibility Investigators. Improved Cardiac Structure and Diastolic Flow Velocities in Early-Stage Heart Failure with Chronic Treatment Using an Implantable system: Results from European and United States Trials of the Rheos® System. JACC 2009:53(10) Supp A, A188.
What are the possible benefits of participating in this clinical trial?
The Rheos® System may: Reduce fluid buildup in your lungs; improve your heart function; help you live longer; increase your quality of life; or reduce the number of hospital stays due to heart failure, but there are no guarantees. Patients in this clinical trial may receive more attention and frequent and detailed follow-up for treatment of heart failure. In the future, other patients may benefit from the results of this trial. However, it is also possible that you may not get any benefit from participating in this trial.
What are the potential risks of participating in this clinical trial?
There are serious and even life-threatening risks and side effects that can happen. The risks of the Rheos® System are listed in the informed consent document that potential patients review before participating in this trial. trial doctors and nurses will discuss details about these risks with you during your meeting when your Informed Consent Form is reviewed. Some of these risks are:
- Surgery/anesthesia complications
- Damage to local blood vessels, nerves and/or baroreceptors
- Infection
- Bleeding
- Pain
- Stroke
- Blood clots
- High or low blood pressure
- Fibrosis
- Slow heart rate
- Need for additional surgery
- Stimulation of nearby tissues
- Death
- Worsening heart failure
How will I know if I can participate?
To participate in the trial, patients must meet a specific set of criteria. First you must answer the initial screening questions in the Enroll in the clinical trial section. If your answers match the criteria, you will be contacted by phone to find out if you meet other important criteria. If your answers match these criteria, CVRx (the trial sponsor) will ask your permission to have your medical records retrieved and reviewed by a doctor at a medical trial site near you. The doctor will then determine if you are able to join the trial.
What is the purpose of this clinical trial?
The purpose of this clinical trial is to evaluate the safety and effectiveness of the the Rheos® System for heart failure.
What type of clinical trial is this?
This study is a randomized clinical trial. This means that participants will be randomly assigned into two groups: system Group or the Medical Management Group. Two out of three patients will have the Rheos® System implanted and continue to receive their medications. These patients will be in the system Group. One out of three patients will continue their medications and will not be implanted with the Rheos System. These patients will be in the Medical Management Group.
Is there a placebo group in this clinical trial?
No there is no placebo group in this trial. The system Group and the Medical Management Group are both treatment groups and will be compared to one another.
If I am accepted into this clinical trial, will I be implanted with the system?
It is possible that you could sign the consent form for the clinical trial, and then have the doctor determine during the screening process that the system is not right for you. If this were to happen, you would not be allowed to take part in the clinical trial. Also, if you are one of the patients randomized to the medications only arm (1 of every 3 randomized patients) you will not get implanted but you will still participate in the trial.
If I participate, what will happen?
All patients who participate in this clinical trial must review an Informed Consent Form with the doctors and/or nurses involved in the clinical trial. The Informed Consent Form describes the clinical trial, including its purpose, length, required tests and procedures, risks and possible benefits. You should carefully review this form and make sure you have all of your questions answered. All patients who wish to be in the clinical trial must sign the Informed Consent Form.
After signing the Informed Consent Form, you will have screening tests to determine if you qualify for the clinical trial. If you qualify, you will be randomly assigned into one of two groups: two out of three patients will have a system implant in addition to their medications and one out of three patients will continue their medications only. All clinical trial participants, whether or not they receive a system, will make an office visit 1, 2, 3, 6, 9, and 12 months after they are randomly assigned. At each of these office visits, you will be asked questions about your health and will have various standard tests (such as blood tests, taking your blood pressure or having an ultrasound).
After the visit at 12 months, all patients will be asked to return for doctor visits once every 3-6 months for up to 5 years after they are randomized.
How often do I have to go to the clinical trial medical site for follow –up visits?
You will go to the clinic at months 1, 2, 3, 6, 9 and 12 after the randomization for follow-up visits. Visits are two to four hours in length. Long term follow up visits will happen at 15 and 18 months. After that point visits will happen every 6 months until the trial closes.
Are clinical trials safe?
The United States government and, specifically, the Food and Drug Administration (FDA) has 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 clinical research trial, a person must agree to sign an Informed Consent form, which provides detailed information about the trial and trial procedures. Experienced doctors who have been thoroughly trained are designated as investigators for the clinical trial. These investigators (doctors) conduct the trial procedures and monitor trial participants. Despite these safeguards, we cannot guarantee that you will receive any benefit from being in this trial or that the system is safe.
For more information on clinical research studies, visit: www.clinicaltrials.gov/ct/info.
Are there costs for participating in the clinical trial?
You will not be charged for tests or procedures required for the trial. CVRx (the trial sponsor) will reimburse the medical center and/or doctors for their fair costs for all of the tests and procedures required for the trial. For patients in the system Group, this includes the medical costs for the screening process, implantation surgery, and follow-up tests and procedures required specifically for the trial and listed in the follow-up schedule of the Informed Consent Form. For patients in the Medical Management Group, this includes only the tests required as part of the screening process, and the doctor visits, tests and procedures required specifically for the trial and listed in the follow up schedule of the Informed Consent Form.
If, during the trial, the system needs to be removed or replaced because you decide you no longer want the system and request that the system be removed, or because the battery runs out, you will not be billed. CVRx will reimburse the medical center and/or doctors their fair costs for those tests and procedures.
CVRx will not pay you or anyone else for any other costs related to your participation in the trial. This includes, but is not limited to any prescriptions you may take, etc. CVRx will also not pay for tests or procedures not required by CVRx for the trial. In particular, CVRx will not pay for the costs of standard medical treatments or hospital stays for heart failure for any patients. Please ask your doctor if you are unsure about whether a specific test or procedure is required for the trial, and what costs will or will not be paid by CVRx.The closest center to me is far away. Will I be paid for my travel expenses?
You will be reimbursed by CVRx (trial sponsor) for reasonable and modest expenses for lodging, meals, train fare, cabs, parking, tolls and mileage, not to exceed $300/ visit.
How will my medical information be kept confidential?
Any information you share with CVRx (the trial sponsor) through this website will be kept confidential and will be shared only with CVRx employees, consultants and the research site staff as described in the Privacy Policy.
If you meet the enrollment criteria to be in the clinical trial, you will be given an authorization form as part of the informed consent process. This form describes exactly what medical records will be disclosed, who can disclose and review those records and how the information will be used in connection with the clinical trial. This form is required by the federal law known as the Health Insurance Portability and Accountability Act (HIPAA). You will be required to review and sign this form before you can be in the clinical trial.
In general, your medical records may be reviewed in connection with the clinical trial by CVRx and its representatives, the hospital/medical center and its doctors and employees, the Institutional Review Board, the Food and Drug Administration (FDA), and other public agencies. Generally, you will not be identified by name in those records. The authorization form details exactly how your information will be protected.What is Informed Consent?
To help you decide if you wish to be a clinical trial participant, you will be given complete information about the clinical trial before you agree to take part. This is known as informed consent. The Informed Consent Form describes the clinical trial, including its purpose, duration, required procedures, risks and possible benefits, compensation, contact information, and describes how the confidentiality of your information will be protected.
The Informed Consent Form will be written in easy-to-understand language and terms. The clinical trial staff will thoroughly review the Informed Consent Form with you. You will have the opportunity to ask the trial doctor or the clinical trial staff questions about the trial, and should make sure they are answered before you decide to be in the trial. If you decide to participate in the clinical trial, you will be asked to sign the Informed Consent Form and you will be given a copy of it to keep for reference throughout your participation in the clinical trial. The Informed Consent Form is NOT a contract and you can leave the clinical trial at any time, for any reason.Can I withdraw from the clinical trial?
Yes. If you decide to withdraw for any reason, at any time, you may do so. Your choice will not jeopardize your care or relationship with your clinical trial doctor. Your decision will not affect your access to future medical care
At the end of the clinical trial is the system removed?
After about 3 years from the beginning of the trial, the information collected will be analyzed, and it is hoped that the information will show that subjects randomized to the Medical Management Group will be able to receive an implant of the Rheos® System, but there are no guarantees.
At the end of the trial, if the system is not approved by the U.S. Food and Drug Administration (FDA), the following options are available to patients implanted with a Rheos System:
- Allow the Rheos System to continue to deliver active therapy until the battery is depleted. At that time a doctor will take out part or all of the system.
- Allow the Rheos System to continue to deliver active therapy until the battery is depleted and then leave the system in place.
- A doctor will turn the Rheos system off and then take out part or all of the system.
- A doctor will turn the Rheos System off and leave it in place.
You should discuss these options with the trial doctor.
What laboratory or other diagnostic tests or assessments are required?
- General Health Assessment
- Evaluation of Medications
- A Survey Regarding your Quality of Life
- Blood Pressure Readings
- Blood Analysis
- Carotid Duplex Ultrasound
- 24 Hour Holter Monitor
- Electrocardiogram (ECG)
- Tissue Doppler
- Echocardiography
How long is the surgery?
The length of surgery varies from person to person. It usually ranges from 3 to 3.5 hours.
How long will I be in the hospital after surgery?
The length of time in the hospital varies from person to person. However, it typically ranges from 1 to 3 days.
Does it hurt?
Surgery is done under general anesthetic so you won’t feel anything. For a few weeks after surgery, you will probably feel normal pain associated with the healing of the scars. The system itself and the electrical stimulation it provides should not cause any pain.
What side of the body is the Rheos® System implanted on?
The system is implanted just under the skin, below the collarbone, on either the left or the right side of the body. It is usually implanted on the right side. The leads (thin wires that attach to the system) are placed around the large vessels on left and right sides of the neck.
Will the system and leads be noticeable under my skin?
If you have a small frame or are thin it is likely that the system will be noticeable as a slight bulge below your collarbone. The leads in the neck should not be noticeable under your skin.
Will the scars be noticeable?
Every person has different healing and scarring results and you should expect some scarring from the surgery. If this is a special concern for you, please discuss it with your clinical trial doctor.
Is it ok to be around microwave ovens?
Yes it is ok to be around microwave ovens.
Can I go on airplanes? How do I go through the airport?
Yes you can go on airplanes. A card will be provided for you to tell security personnel that you have an implanted system.
Can I still be active? What activities are ok?
The system should not prevent you from your normal daily activities. However, you will need to check with the trial doctor who can determine, based on your health status, what activities are okay for you and which are not.
Can I get MRIs after implant?
No, you cannot get MRIs once you are implanted with the Rheos® System. You can however get other imagine tests done such as CT-scans and echocardiogram.
Does this system help or hinder erectile dysfunction or sexual activity?
There is no reason to believe that this system would cause erectile dysfunction. Actually, high blood pressure has been shown to be a risk factor for erectile dysfunction. To the degree that this system may lower your blood pressure your risk of developing erectile dysfunction may be reduced.
Can women who are pregnant participate in the clinical trial?
No, Women who are pregnant are not permitted in this trial.
How many people have been implanted with the Rheos® System so far?
As of May 1st, 2010, 400 people have been implanted with a Rheos® System.
How many other clinical trials have been done with the Rheos® System?
Two clinical studies including 61 patients with high blood pressure have been completed, and one clinical trial including 300 patients with high blood pressure is currently underway. This clinical trial is one of two heart failure studies currently underway.
Can I follow up with a center different from the one I am implanted at?
Patients are expected to stay with the same center throughout the clinical trial. Special cases will be evaluated on a case by case basis.
What is the length of the battery life of the system?
Our experience has been that batteries last 14 months on average.
Can the settings of the system be changed without surgery?
Yes. The system is programmed by a trained nurse or doctor using telemetry (a technology similar to the one used in TV remote controls).
What happens at the end of the trial?
After about 3 years from the beginning of the trial, the information collected will be analyzed, and it is hoped that the information will show that subjects randomized to the Medical Management Group will be able to receive an implant of the Rheos® System, but there are no guarantees.
At the end of the trial, if the system is not approved by the U.S. Food and Drug Administration (FDA), the following options are available to patients implanted with a Rheos System:
- Allow the Rheos System to continue to deliver active therapy until the battery is depleted. At that time a doctor will take out part or all of the system.
- Allow the Rheos System to continue to deliver active therapy until the battery is depleted and then leave the system in place.
- A doctor will turn the Rheos system off and then take out part or all of the system.
- A doctor will turn the Rheos System off and leave it in place.
How long until the Rheos® System is approved by the U.S. Food and Drug Administration?
It is possible that the Rheos System may be approved for resistant high blood pressure sometime in 2012. It is possible that the system may be approved for Heart Failure in 2014.
What are the results of high blood pressure studies to date?
The latest data published shows that patients have had an average drop of 35 mmHg in systolic blood pressure (top number in a blood pressure reading) at 3 months. They have maintained this lowered blood pressure for up to three years.
Who is the clinical trial sponsor?
CVRx is a private company located in Minneapolis, MN. The company has developed proprietary technology for the treatment of high blood pressure and heart failure. The senior management and technical team at CVRx have many years of experience in the implantable medical systems industry.
The clinical trial 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.
CAUTION: Investigational system. Limited by Federal (or United States) law to investigational use.