Efficacy and Safety of Micra AV2 Transcatheter Pacing System

Prospective, single-arm, multi-centre clinical study to characterize the chronic efficacy and safety profile of CE approved and market released Micra AV2 A sample size of approximately 150 subjects implanted with a Micra AV2 is required to evaluate the different objectives. A minimal sample size of 50 subjects with persistent 3rd degree AVB and normal sinus node function is required to evaluate the ambulatory AV synchrony at 6-month follow-up.

Primary objective:

Characterize ambulatory AV synchrony in subjects with persistent third degree AV block and normal sinus node function at 6-month post Micra AV2 implant procedure

Secondary objective(s):

• Characterize the AV synchrony and device behaviour during exercise in subjects with persistent third degree AV block and normal sinus node function at 6-month post implant procedure
• Characterize the evolution of left ventricular function at 12-month post implant
• Evaluate the efficacy of the 'Atrial Sensing Setup' at the end of the implant procedure
• Long-term follow-up (3 years) to evaluate AV synchrony, need for system revision and complication rate including rate of pacing induced cardiomyopathy

Inclusion criteria

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• At least 18 years of age at the time of signing the Informed Consent Form (ICF)
• Participant will be implanted with a Micra AV2 for an approved indication for use
• Participant with a history of any type of high-degree AV block
• Participant is willing and able to comply the study protocol

Exclusion criteria

-1. Subject implanted with a Micra AV2 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 Micra AV2 implant procedure) 3. Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study.

• Subject meets any exclusion criteria required by local law (age or other)