BIOTRONIK Clinical Studies IMPACT Clinical Study Patient Information. IMPACT Clinical Study: Patient Information Guide

BIOTRONIK Clinical Studies IMPACT Clinical Study Patient Information IMPACT Clinical Study: Patient Information Guide

Introduction and Objectives IMPACT is a clinical research study. Approximately 2,700 patients are expected to participate in this worldwide study. Your doctor has found that you are eligible for the study and interested to know if you are willing to participate. The purpose of IMPACT is to study whether early awareness of an abnormal heart rhythm, detected by Home Monitoring, in combination with blood thinning medication is able to reduce the risk of stroke and blood clots. Additionally, safe and early stop of blood thinners will be assessed to see if bleeding can be reduced. This brochure will help you understand basic information and background regarding IMPACT. However, you should ask your doctor to provide you with more information to help you decide whether participating in IMPACT is right for you. 1

Atrial Fibrillation Basics Atrial fibrillation (also referred to as AF or Afib) is the most common type of irregular and rapid heartbeat. It is found in about 2.2 million Americans, and the chances of it occurring increases with a person s age. The general population has about a 25% lifetime chance of developing AF. Atrial fibrillation increases the risk of stroke. About one-sixth of all strokes are caused by AF. Over 25% of strokes in patients over 70 years old are likely caused by AF. Damage to the heart s structure is the most common cause of atrial fibrillation. Possible causes of AF include: High blood pressure Heart attacks Abnormal heart valves Heart damage you are born with An overactive thyroid or other metabolic imbalance Exposure to chemicals such as medications, caffeine, tobacco, and alcohol Improper functioning of the heart s natural pacemaker (sinus node) Emphysema or other lung diseases Previous heart surgery Viral infections, pneumonia 2

During AF, the heart s two upper chambers (atria) beat out of coordination with the two lower chambers. The atria do not empty all of the blood, which can cause the leftover blood to form clots. If a clot goes into your blood stream, it can cause a stroke. A heart in AF is not able to pump enough blood to the body with each heartbeat. Symptoms may be experienced, such as heart palpitations (irregular or violent heart beats), chest discomfort, dizziness, shortness of breath, and weakness. Some people with AF have no symptoms and are unaware of their condition until discovered during a physical examination. Treatments for atrial fibrillation may include medications that thin your blood, and other interventions that change the heart s conduction system. 3

Home Monitoring Basics What is Home Monitoring? The BIOTRONIK implanted defibrillator that you have received provides the benefit of a new technology called Home Monitoring. The name means exactly what it suggests: monitoring of your heart and the functions of the implanted device can be done automatically from your home. What is the CardioMessenger? Home Monitoring works together with a small device called the CardioMessenger. The CardioMessenger may either be carried by you or remain at your home. The CardioMessenger's job is to communicate using the worldwide cellular telephone network or a landline connection at no additional cost to you. 4

Messages Straight from the Heart The implanted devices that contain Home Monitoring are equipped with a special transmitter. Using an integrated antenna, the implant automatically sends medical and technical information from your heart to your treating physician via the CardioMessenger. This allows your physician to keep an eye on you, even when you are far away, and to evaluate your condition based on accurate, up-todate clinical information. An automatic alert is sent to your doctor, even if you are unaware that you are experiencing an irregular heartbeat. 5

Study Participation Groups As a study participant, you would be assigned randomly (like tossing a coin) into one of the two study groups. You have a 50% chance of being assigned to either of the two groups: Intervention patients will have Home Monitoring (HM) fully enabled and will have continuous monitoring of their heart rate and rhythm. This means that the information your study doctor usually collects during an office visit will be sent through the HM system. You will still need to see your study doctor at your scheduled office visits. Your study doctor will then review the information about your heart securely on the HM website to assess your need for treatment with a blood thinning medication. If the HM assessment shows an atrial arrhythmia or abnormal heart rhythm, your study doctor will use the assessment to prescribe warfarin according to a specific schedule or plan. Your heart rhythm and medical condition will determine how early you will be asked to start the blood thinning medication plan. Control patients will have their Home Monitoring feature turned ON or active, but not fully enabled. This means that your study doctor will not be able to see how your heart and study device are functioning using the HM features of your device. BIOTRONIK personnel will be able to access HM to make sure your implanted device is functioning properly. Many implanted systems do not offer the HM technology; therefore, not having HM data access is still fairly common, and is currently considered the standard of care according to therapy guidelines for patients like you. Your study doctor will see you at scheduled office visits. If your heart rhythm is abnormal, your study doctor will treat you appropriately. 6

Anticoagulation Therapy Warfarin is a medication used to thin your blood. It is known as an anticoagulant. Anti means against, and coagulant refers to blood clotting. Warfarin reduces the body s ability to make blood clots. Your doctor may want you to take warfarin to reduce the risk of your body making clots, which can cause a serious medical problem. For example, if a clot moves to your brain, it can cause a stroke. Warfarin begins to reduce blood-clotting within 24 hours after taking the drug. The full effect may take 72 to 96 hours to occur. It is important for you to take your dose as prescribed by your doctor. Warfarin is monitored by a blood test (the INR test). This medication has a very narrow range where it is considered therapeutic, meaning in the best range to be beneficial to you. This is why it is so important to get your blood tests done regularly. 7

Specific Patient Requirements and Responsibilities What will you need to do in order to participate in IMPACT? After being enrolled in the study, you will be required to come to the clinic every three months or every six months for a follow-up visit. Your doctor or study coordinator can tell you which schedule your visits will follow. Patients participating in IMPACT must be able and willing to come to regular doctor visits: At each follow-up visit, you will be asked questions by your doctor or study coordinator. You must be able and willing to provide this information regarding your health and wellbeing since your last visit If your study doctor feels that you had, or may have a stroke, you will need to see a neurologist (doctor who specializes in the nervous system). This would be done even if you were not in this study. You will need to bring a list of all the medications you are taking to each of your study doctor visits If your study doctor prescribes you warfarin (coumadin), you may need to keep a diary documenting your medication changes 8