N/A
Completed N=157
Accelerometer Sensing for Micra AV Study
AV Block · AV Block Complete · 3rd Degree Heart Block · Complete Heart Block
Source: ClinicalTrials.gov NCT04245345 ↗
Enrolled (actual)
157
Serious AEs
28.7%
Results posted
Feb 2023
Primary outcomePrimary: Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function — 85.4 Percentage of P-waves
Summary
The purpose of the AccelAV Study is to characterize chronic AV synchrony in subjects implanted with MicraTM AV device. This study will be conducted upon market approval of the MicraTM AV Transcatheter Pacing System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node Function |
85.4 | — |
| SECONDARY Stability of AV Synchrony During Rest Between 1-month and 3-months Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function |
86.1; 84.1; -2.0 | — |
| SECONDARY Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node Function |
74.5 | — |
| SECONDARY Left Ventricular Outflow Tract Velocity Time Integral |
21.4; 23.7; 2.3 | — |
Eligibility Criteria
Inclusion Criteria
Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication.
- Subject has history of AV block.
- Subject is ≥ 18 years old and as per required local law.
- Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
- Subject is willing and able to comply with the protocol.
Exclusion Criteria
- Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist.
- Subject implanted with a MicraTM (Model MC1AVR1) on a non-permanent basis (e.g. CIED infection).
- Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MicraTM Model MC1AVR1 implant procedures).
- Subject meets any exclusion criteria required by local law (age or other).
Data sourced from ClinicalTrials.gov (NCT04245345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.