Aveir Dual-Chamber Leadless i2i IDE Study
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Bradyarrhythmia
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Age: Between 18 years - 150 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
- Has a life expectancy of at least one year
- Willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
- Understands the nature of the protocol and agrees to adhere to the study procedures
- Provides signed written informed consent
You may not be eligible for this study if the following are true:
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- Are not allowed to take part in other investigational research projects involving administration of any drug or substance
- Pregnancy or lactation
- Known presence or suspicion (based on clinical or laboratory parameters) of other neurologic disorders that may mimic MS
- Known active bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds
- Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to Day 1 visit
- History or known presence of recurrent or chronic infection
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation.
- History or laboratory (local laboratory test) evidence of clinically significant coagulation disorders
- Peripheral venous access that precludes IV administration and venous blood sampling as required per study protocol
- Inability to complete an MRI scan
- Teeth braces interfering with MRI acquisition
- History of cancer
- Currently active alcohol or drug abuse or history of alcohol or drug abuse
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.