NCT07356505 Efficacy and Safety of Micra AV2 Transcatheter Pacing System
| NCT ID | NCT07356505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | AV Block Complete |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-01-12 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF) 3. Participant will be implanted with a Micra AV2 for an approved indication for use 4. Participant with a history of any type of high-degree AV block 5. 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. 4\. Subject meets any exclusion criteria required by local law (age or other)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07356505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AV Block Complete. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07356505 currently recruiting?
Yes, NCT07356505 is actively recruiting participants. Contact the research team at christophe.garweg@uzleuven.be for enrollment information.
Where is the NCT07356505 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07356505 clinical trial?
NCT07356505 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 150 participants.