Actively Recruiting
Efficacy and Safety of Micra AV2 Transcatheter Pacing System
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-01-21
150
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Micra AV2 Transcatheter Pacing System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening
- At least 18 years old at the time of consent
- Planned implantation with a Micra AV2 for an approved use
- History of any type of high-degree AV block
- Willing and able to follow the study protocol
You will not qualify if you...
- Implanted with a Micra AV2 on a temporary basis (e.g., due to infection)
- Pregnant women (pregnancy test required if applicable)
- Currently enrolled or planning to enroll in a conflicting drug or device trial
- Meets any exclusion criteria required by local law (such as age restrictions)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals of Leuven
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
Research Team
C
Christophe Y Garweg, Professor
CONTACT
C
Caroline Devooght, Miss
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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