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:

  • Conditions:
  • Age: Between 18 - 150 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
    2. Has a life expectancy of at least one year
    3. Willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
    4. Understands the nature of the protocol and agrees to adhere to the study procedures
    5. Provides signed written informed consent

You may not be eligible for this study if the following are true:

    1. Are not allowed to take part in other investigational research projects involving administration of any drug or substance
    2. Pregnancy or lactation
    3. Known presence or suspicion (based on clinical or laboratory parameters) of other neurologic disorders that may mimic MS
    4. Known active bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds
    5. Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to Day 1 visit
    6. History or known presence of recurrent or chronic infection
    7. Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation.
    8. History or laboratory (local laboratory test) evidence of clinically significant coagulation disorders
    9. Peripheral venous access that precludes IV administration and venous blood sampling as required per study protocol
    10. Inability to complete an MRI scan
    11. Teeth braces interfering with MRI acquisition
    12. History of cancer
    13. 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.