Download 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.
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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:
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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
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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.
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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.
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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.
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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.
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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.
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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
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