Left Atrial Pressure Monitoring To Optimize Heart Failure Trial
Your doctor may feel that you could be an appropriate candidate for a new medical study called the Laptop-HF Trial.
St. Jude Medical is a company that designs and manufactures medical devices used in the treatment of people with heart conditions. St. Jude Medical is currently undertaking a clinical trial called LAPTOP-HF, which is designed to test a new method of treatment for heart failure) patients.
The following information provides you with a general idea of what would be involved in participating as a patient in this study. If you are interested in learning more about being a participant in LAPTOP-HF, you should talk about the study at greater length with your doctor or the research nurse to make sure you understand everything that is involved. You may also want to discuss it with family members or close friends. Before participation, you will be asked to read and sign a more detailed consent form.
- What is the purpose of the study? LAPTOP-HF is designed to investigate a new way to help treat heart failure. Since many heart failure patients are frequently hospitalized and often feel poorly, the hope is that this system may help your doctor adjust your medications before you develop symptoms or require hospitalization. This is accomplished by measuring pressure in the heart and then each day providing you with your physician’s updated recommended medications and dosages. These may change daily depending on your condition. This is very similar to how diabetics manage their glucose levels.
- What will I have to do if I participate in the study? Participants will be randomly divided into two groups. One group will have a study device implanted; the other will not. Both groups will receive a handheld device that reminds them to take their medications. You may have heard of medical devices commonly called “pacemakers.” The study devices will be implanted in much the same way as pacemakers: they are placed under the skin in the chest and special, insulated wires called “leads” are connected to the heart through a vein and then attached to the device. One of these leads is a special lead that has a sensor that will measure pressures inside the heart. The information detected by the sensor is stored in the handheld device.
- Is the implant procedure dangerous? All surgical procedures carry risks and should never be entered into lightly. While surgery to implant pacemakers has become very common, devices implanted into the human body that interact with the heart can possibly cause complications. Furthermore, because LAPTOP-HF involves a new procedure to place the lead with the sensor, not all of the risks are known or can be predicted. Before you decide to participate, you will be given as much time as you need to discuss the risks and possible side effects involved in the surgery and to have all of your questions addressed.
- What happens after I receive the study device? If you receive a study device, it will collect information about your heart through the pressure sensor lead. In order to store this information, you will be given a handheld device called the Patient Advisor Module (PAM® module), which you will keep with you at all times. The PAM module has been designed to be simple to use. You will be taught how to operate it after the implant procedure, before you are discharged, and given simple-to-follow instructions to take home with you. It will be your responsibility to follow carefully the dosing instructions that the PAM module gives you.
- What does the PAM module do? The PAM module reminds you when to take your medications, and it allows you to record how you are feeling. If you have an implanted study device, the PAM module downloads information from your implanted device and periodically transmits information to your doctor’s office over a normal telephone line. The doctor uses a specially designed computer program to check your heart’s performance and provide the medications and dosages you should be taking. The information is then sent back to you via the PAM module along with any medical instructions your doctor may have for you.
- How often will I have to visit my doctor after the device is implanted? After you enter the study, you will need to visit the study clinic after two weeks, six weeks, three months, six months, nine months and 12 months. After that, you will need to visit every three months until the study is completed. These visits will allow your doctor to monitor your health status and perform routine tests.
- How long will the study last? Your participation will last approximately five years. After the first year, though, you will only have four follow-up appointments per year until the end of the study.
- Will taking part in the study help me feel better? There is no guarantee that you will benefit from taking part in this study. You will be given reminders to take your medication. The purpose of the study is to test a new treatment, so we cannot yet say whether or not the treatment will be beneficial. However, you will be given “gold standard” medical attention and our participation will help us to learn things about treating heart failure that could benefit others in the future.
- What if I am not interested in taking part in the study? Will that affect my relationship with my doctor? Taking part in this – or any clinical trial – is entirely voluntary. You should not feel any pressure to participate if you are not certain that you wish to do so. If you decide not to take part, you will not suffer any penalty or lose any benefits to which you are otherwise entitled.
- What if I agree to take part, but then change my mind? Can I withdraw my consent? Yes – you may withdraw from the study at any time without any penalty or loss of benefits to which you are otherwise entitled. If you choose to withdraw after having agreed to participate, you should discuss your heart failure follow-up needs with your doctor to make sure you continue to receive the care you need.
- If I am interested, what should I do next? Contact your physician or The University of Kansas Hospital Research team (913.588.9679) and let them know that you would like to learn more about the St. Jude Medical LAPTOP-HF clinical trial. Make time to talk to them in detail about what is involved in the study and to find out whether you qualify to participate.
The LAPTOP-HF clinical study
Experience at a glance
- Discuss the details of the trial with your physician, family members and friends.
- If you decide to enroll in the trial, you may be implanted with a left atrial pressure sensor.
- If you are implanted with a sensor, you will also receive a PAM® module, which you will use to transmit data from your implanted device to your physician.
- If you are given a PAM module, your physician will use it to communicate medication and dosage information to you.
- If you have a PAM module during the study, you will be required to comply with your physician’s prescriptions and instructions that you will receive via the module.
- You will attend in-clinic follow-ups for the duration of the study.