18 and older, any sex, with AV Block or AV Block Complete. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Atrioventricular (AV) Synchrony During Rest at 1-month Post-implant in Subjects With Persistent 3rd Degree Atrioventrcular Block (AVB) and Normal Sinus Node FunctionPrimary· 1-month post-implant
Atrioventricular synchrony is defined for each P-wave during the 20-minute resting period. Specifically, for each electrocardiogram (ECG) confirmed P-wave that occurs during the 20-minute resting period at the 1-month visit, the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentage is the average percentage of P-waves considered synchronous across all patients during the 20-minute resting period.
Group
Value
95% CI
AccelAV Evaluable for Primary Objective
85.4
81.1 – 88.9
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 FunctionSecondary· Between 1-month and 3-months post-implant
AV synchrony is defined for each ECG confirmed P-wave that occurs during the 20-minute resting period at both the 1-month visit and 3-months visits. For each P-wave the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentages are the average percentage of P-waves considered synchronous across all patients during the 20-minute resting period at each visit (month 1 or month 3).
AV synchrony at 1-month
Group
Value
95% CI
AccelAV Evaluable for Secondary Objective
86.1
81.2 – 89.9
AV synchrony at 3-months
Group
Value
95% CI
AccelAV Evaluable for Secondary Objective
84.1
78.3 – 88.6
Difference in AV Synchrony (Month 3 - Month 1)
Group
Value
95% CI
AccelAV Evaluable for Secondary Objective
-2.0
-6.8 – 2.9
Percentage of Ambulatory AV Synchrony at 1-month Post-implant in Subjects With Persistent 3rd Degree AVB and Normal Sinus Node FunctionSecondary· 1-month post-implant
AV synchrony is defined for each P-wave during the the 24-hour Holter monitoring period while the subject went about their activities of daily living. Specifically, for each electrocardiogram (ECG) confirmed P-wave that occurs during the 24-hour Holter period at the 1-month visit, the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 ms following an ECG confirmed P-wave. The reported percentage is the average percentage of P-waves considered synchronous across all patients during the 24-hour Holter monitoring period.
Group
Value
95% CI
AccelAV Evaluable for Primary Objective
74.5
70.4 – 78.2
Left Ventricular Outflow Tract Velocity Time IntegralSecondary· Within 48 hours of procedure
Characterize the change in stroke volume, as measured by left ventricular outflow tract (LVOT) velocity time Integral (VTI), during Micra AV mediated VDD (atrioventricular synchronous ventricular pacing) pacing and VVI (asynchronous ventricular pacing) pacing in subjects with persistent 3rd degree AV block and normal sinus node function
LVOT VTI during VVI mode
Group
Value
95% CI
AccelAV Evaluable for Secondary Objective
21.4
19.7 – 23.1
LVOT VTI during VDD mode
Group
Value
95% CI
AccelAV Evaluable for Secondary Objective
23.7
21.7 – 25.6
LVOT VTI difference (VDD-VVI)
Group
Value
95% CI
AccelAV Evaluable for Secondary Objective
2.3
1.5 – 3.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the time of consent through 3-month follow-up.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System
· NA
· recruiting
NCT06910059 — The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Ech
· active not recruiting
NCT06707662 — Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
· NA
· recruiting
NCT06197503 — Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI
· NA
· recruiting
NCT05650658 — Left vs Left Randomized Clinical Trial
· NA
· recruiting
Other Medtronic Cardiac Rhythm and Heart Failure trials
Trials by the same sponsor.
NCT06910059 — The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Ech
· active not recruiting
NCT06745778 — Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
· recruiting
NCT06540521 — Bolt CSP-M Holter Study
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medtronic Cardiac Rhythm and Heart Failure
Last refreshed: 23 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04245345.