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
83 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
Researchers are evaluating the Micra AV2, a third-generation leadless pacemaker designed to improve heart rhythm control in patients with high-degree atrioventricular (AV) block and normal sinus rhythm. This study aims to assess the device's ability to maintain AV synchrony, especially during exercise, and to monitor its safety and effectiveness over time in real-world use. The study is a prospective, single-arm, multi-center clinical trial involving patients implanted with the Micra AV2 device. All participants will receive the Micra AV2 leadless pacemaker, which features new algorithms to enhance AV synchrony at higher heart rates compared to previous models. The device also offers a potential battery life extension of over 44%. The study will follow patients for up to three years, with key evaluations at 6 and 12 months post-implant to assess AV synchrony during daily activities and exercise, as well as left ventricular function. The implant procedure is the same for all participants. Participants will undergo scheduled follow-ups to monitor heart rhythm synchronization and device performance, including assessments at 6 months for AV synchrony and exercise response, and at 12 months for heart function changes. Long-term follow-up will evaluate the need for device revisions and monitor for complications such as pacing-induced heart issues. Safety and device efficacy will be continuously assessed throughout the study period, which extends until 2029.
CONDITIONS
Brief 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 any screening
- At least 18 years old at the time of consent
- Scheduled to be implanted 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 join another conflicting drug or device trial
- Any exclusion criteria required by local laws (such as age restrictions)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo implantation of the Micra AV2 leadless pacemaker and receive immediate post-procedure care.
1 implant procedure visit (in-person)
Duration - Up to 3 years
Participants have the Micra AV2 device implanted and are monitored during active treatment.
Regular follow-up visits for device monitoring and assessment
Duration - Up to 3 years after implant
Participants are followed long-term to evaluate AV synchrony, device performance, and any complications including pacing induced cardiomyopathy.
Scheduled follow-up visits at 6 months, 12 months, and annually up to 3 years
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
C
Caroline Devooght, Miss
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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