Belgo-Luxembourg Leadless PM Registry

• CT scan heart (Radiation): Acquisition of a CT scan heart to define the exact position of the atrial an ventricular leadless pacemaker
• 24 hour ambulatory ECG monitoring (Diagnostic test): 24 hour ambulatory ECG monitoring

Primary outcomes

• Assessment of safety [1/6-month, 1-year and 2-year]: The primary safety endpoint is 1/6-month, 1-year and 2-year incidence rate of leadless device-related or procedure-related major complications. In this context, the implant procedure will also be summarized. Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision.
• Assesment of Electrical Efficacy: capture threshold [12 and 24 month FU]: Ventricular pacing threshold is considered acceptable if <2.0 V at 0.4 ms Atrial capture threshold is considered acceptable if ≤3.0 V at 0.4 ms
• Assesment of Electrical Efficacy: R-wave and P-wave amplitude [12 and 24 month FU]: R-wave amplitude is considered acceptable if >5.0 mV P-wave amplitude is considered adequate if ≥1.0 mV.
• Assesment of Efficacy: i2i communication betwoon both pacemakers [12 and 24 month FU]: Acceptable i2i communication is defined as >80% in AVEIR DR systems as measured.
• AV synchrony and i2i communication in patients with high-degree AV block. [12-months]: The i2i communication between both devices will be also specifically assessed in patients treated with Aveir DR for permanent high degree AV block (>80% VP). This will be validated by the acquisition of an ambulatory holter at the 12-month follow-up.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Participants eligible for inclusion in this investigation must meet all of the following criteria:

  1. Voluntary written informed consent has been obtained from the participant or their legally authorized representative prior to any screening procedures.
  2. Participant is at least 18 years of age, or of legal age of consent, at the time of signing the Informed Consent Form (ICF).
  3. Participant has a clinical indication for cardiac pacing in accordance with the 2021 ESC Guidelines on Cardiac Pacing1.
  4. Participant is willing and able to comply with all study requirements as specified in the study protocol.

Exclusion Criteria:

* Participants eligible for this Investigation must not meet any of the following criteria:

  1. Subject implanted with an Aveir device on a non-permanent basis (e.g., CIED infection)
  2. Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to implant procedure)
  3. Subject currently enrolled or planning to participate in a potentially confounding drug or device study during the study.
  4. Subject meets any exclusion criteria required by local law (age or other).
  5. Subject has life expectancy less than 12 months.
  6. Subject is implanted with an electrically active implantable medical device with stimulation capabilities at risk to be impacted by the Aveir Link Module telemetry.
  7. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with the site standard follow-up visits, for example a mechanical tricuspid valve prosthesis or vein thrombosis, which could impede the delivery of implantable devices as planned by the implanters.
  8. Subject is allergic/hypersensitive to <1 mg dexamethasone sodium phosphate.