Aveir DR i2i Study

Launched by ABBOTT MEDICAL DEVICES · Feb 17, 2022

Keywords

ClinConnect Summary

The Aveir DR i2i Study is a clinical trial that is investigating the safety and effectiveness of a new type of device called the Aveir™ Dual-Chamber Leadless Pacemaker. This device is designed to help people with certain heart rhythm problems, particularly those who may have a condition called bradycardia, where the heart beats too slowly. The study is currently active, but it is not recruiting new participants at this time.

To be eligible for the study, participants must be at least 18 years old and have a life expectancy of at least one year. They also need to meet specific heart health guidelines related to the use of dual-chamber pacemakers. It’s important that participants are willing to attend follow-up visits and tests as part of the study. However, some individuals, such as those who are pregnant, have certain medical conditions, or are involved in other clinical trials, may not qualify. If someone joins the trial, they can expect regular check-ups to monitor their health and the performance of the pacemaker over time.

Gender

ALL

Eligibility criteria

• 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. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
• • 3. Subject has a life expectancy of at least one year
• • 4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
• • 5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC
• 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 presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
• • 4. 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
• • 5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
• • 6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
• • 7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
• • 8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
• • 9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
• • 10. Subject is unable to read or write