Efficacy and Safety of Micra AV2 Transcatheter Pacing System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
A third generation, Micra AV2 is now available and proposes increased automaticity and improved AV synchrony algorithms based on computing model. The new algorithms permit the delivery of AV synchronous pacing, improving the automatic AV synchrony at faster heart rates between 80-100 bpm with a maximal upper tracking rate limit of 135 bpm (previously 115-120 bpm in the Micra AV1). Micra AV2 presents also a potential extended longevity of 15.6 years (increased by \> 44% in comparison of Micra AV1). Up to now, no clinical study has evaluated the efficacy and safety of Micra AV2 in a real-world setting.
The focus of this study is to characterize chronic ambulatory AV synchrony in patients with high degree AV block and normal sinus rhythm implanted with a Micra AV2 as primary objective to evaluate AV synchrony during exercise as secondary objective.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov