Patient Information Sheet
Learn more about Aveir DR and the i2i study
An investigational clinical trial designed to assess the safety and effectiveness of the Abbott dual-chamber Aveir™ Leadless Pacemaker (LP) System in patients with slow or irregular heartbeats
What is a Slow or Irregular Heartbeat?
An irregular heartbeat is called an arrhythmia (uh-RITH-me-uh), which occurs when the electrical signals that coordinate your heartbeats don’t work properly. The faulty electrical signals may cause the heart to beat too slow (bradycardia), too fast (tachycardia) or irregularly.
These irregular rhythms do not allow the heart to pump enough blood to the body. This may cause you to feel tired, dizzy, lightheaded, short of breath or other symptoms. Arrhythmias can be caused by problems with the heart’s electrical system, advanced age, heart attack, a heart condition present at birth or certain medications.
What is a Pacemaker?
People who experience an irregular heartbeat may receive a pacemaker to help restore a more normal heart rhythm.
A pacemaker is one of the ways to treat arrhythmia and maintain a healthy heart rhythm. The pacemaker monitors your heart rate and if your heart beats irregularly or too slowly, the pacemaker can provide painless electrical pulses to stimulate your hearts contraction.
Traditional Pacemaker with Leads
A traditional pacemaker is implanted under the skin in the chest area and connected to insulated wires, or leads, that attach and deliver electrical energy to the heart wall.
Leadless pacemakers are placed in the heart using a small tube through a blood vessel in your leg. The devices are directly implanted into the top and bottom chambers of the right side of the heart. These devices will deliver the electrical energy needed for your heart to contract, managing the irregular rhythm.
WHAT IS A CLINICAL TRIAL?
Clinical trials are research studies in which people volunteer to help find answers to specific health questions.1 When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.
Clinical trials are conducted according to a plan, called a protocol, which describes:
Volunteers who participate in the study must agree to the rules and terms outlined in the protocol. Similarly, researchers, doctors, and other health professionals who manage the clinical trials must follow strict rules. These rules make sure that those who agree to participate are treated as safely as possible.
WHY PARTICIPATE IN A CLINICAL TRIAL?
Clinical trials can help advance modern medicine. They can lead to new ways to diagnose and treat disease and improve our understanding of our health and how we can fight and prevent disease. Learning more about these types of trials helps us better understand just how important this type of research is to creating life-saving technologies, including new medical devices and medications.
Some people may join a trial because the treatments they have tried for their health problem did not work or because there is no treatment available. By being a part of a clinical trial, participants may gain access to new treatments before they are widely available.
INNOVATING FOR ACCESS AND AFFORDABILITY
It is well known that in the United States and other parts of the world, women and people of diverse ethnic and cultural backgrounds are disproportionally impacted by cardiovascular disease and are considerably underrepresented in the clinical trials process.2 This limits access to the most advanced treatments and worsens the challenges around health care equity and prevents us from understanding how different groups may respond to different treatments and therapies. Regulatory bodies like the U.S. FDA have developed guidance for sponsors of clinical trials to enroll patient populations that reflect the population needing the treatment or therapy.3 Abbott is doing its part to transform care by intentionally designing access and affordability into our life-changing technologies.4 For this study, Abbott has developed some tools and resources designed to make it easier for you to participate in this clinical trial.
Key Inclusion Criteria*
1. Subject must have at least one of the clinical indications before device implant in adherence with current dual-chamber pacing guidelines
2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
3. Subject has a life expectancy of at least 1 year
Key Exclusion Criteria*
1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
3. Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood-or tissue-contacting material listed in the IFU
4. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
5. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
6. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
7. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular LP)
8. Subject is implanted with an electrically active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)**
9. Subject is unable to read or write
What to Expect if you Participate in the Trial?
Before you are enrolled, you will assessed to make sure you qualify for this study. Your screening will include:
1. An in-person visit with a heart rhythm specialist (electrophysiologist)
2. An electrocardiogram (EKG)
3. A review of your medical history
If the screening process shows you are the right candidate for the trial and you agree to participate in the study, you will receive an Aveir DR Leadless Pacemaker System.
Is this Study Right for Me?
You may be eligible for the Avier DR i2i trial if:
* May not be inclusive of all inclusion and exclusion criteria. Please refer to clinical investigation plan for a detailed list
**Does not apply to a medical device with no known impact to the Aveir Leadless Pacemaker System, including the Aveir Link Module. Patient evaluation and the decision to implant the LP should take into account the presence of other active implantable devices and should include consultation with the Sponsor and/or manufacturer of the co-existing device.
CAUTION: Investigational device. Limited by Federal law to investigational use only.
Device has not been tested for use with MRI.
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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
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