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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
DeviceAll patients will be implanted with aMicra AV2 leadless pacemaker
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Micra AVExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AV synchrony at 6 months
AV synchrony will be computed on an individual heartbeat basis and is defined as met for paced or sensed ventricular beats that are within 300 ms following an ECG confirmed P-wave. This endpoint will be used for the primary objective , for the secondary objective #1 (AV synchrony during exercise at 6-month post-implant) and for the secondary objective #3 (evaluation of the AV synchrony following the automated atrial sensing setup)
Time frame
6 months follow-upSponsors and contacts
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov