bradycardia slow-heartrate
Conditions
Interventions
2 Leadless pacemakers are implanted in all subjects. If a subject already has a 
leadless Aveir implanted, a second Aveir is placed in the right atrium.
Sponsors
Abbott Medical
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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 LP) 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 *NOTE: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary safety endpoint evaluates the 12-month Aveir atrial LP complication free rate in de novo subjects based on CEC adjudication of adverse events. The secondary effectiveness endpoint evaluates the appropriate and proportional rate response of the atrial LP in de novo subjects during graded exercise testing (chronotropic assessment exercise protocol *CAEP*). | — |
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint evaluates the 12-month Aveir DR LP system complication-free-rate in de novo subjects based on CEC adjudication of adverse events. The primary effectiveness endpoint #1 evaluates the 12-month composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. The primary effectiveness endpoint #2 evaluates the 3-month AV synchrony success rate at rest while seated in de novo subjects. | — |
Countries
Netherlands
Outcome results
None listed