Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.

The primary analysis population for the primary safety endpoint was based on subjects in the full analysis population. The full analysis population included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant. A de novo subject was a subject who did not have an implanted pacemaker on the date of consent through the date of the attempted Aveir LP implant

Aveir DR Leadless Pacemaker system complication-free-rate in de novo subjects. A complication was defined as a device-or-procedure-related serious adverse event. Complications included Atrial LP, Ventricular LP, and implant procedure-related complications. Complications possibly related or related to COVID-19 were excluded.

The primary analysis population for the primary safety endpoint was based on subjects in the full analysis population. The full analysis population included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant. A de novo subject was a subject who did not have an implanted pacemaker on the date of consent through the date of the attempted Aveir LP implant.

Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the primary effectiveness endpoint #1 if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 3-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 3-month visit.

Among the 300 subjects in the full analysis population, 3 subjects were excluded due to unsuccessful atrial device implant and unmeasurable p-wave amplitude.

Composite success rate of acceptable atrial pacing thresholds and P-wave amplitudes in de novo subjects. A subject was considered to have met the success criteria for the endpoint if the pacing threshold voltage was ≤ 3.0 V at 0.4 ms at the 12-month visit and the sensed P-wave amplitude was ≥ 1.0 mV at the 12-month visit.

Out of 300 subjects, 8 subjects were excluded from primary effectiveness endpoint. 2 were excluded for unsuccessful atrial device implant and 6 were excluded due to unmeasurable P-wave amplitudes and pacing voltages at the 12-month visit due to atrial fibrillation/ atrial tachycardia.

AV synchrony success was defined as subjects with a paced or sensed ventricular beat within 300 ms following a paced or sensed atrial beat (i.e., a synchronous cycle) for at least 70% of evaluable cardiac cycles.

Out of 300 subjects in the full analysis population, 2 were excluded due to unsuccessful atrial implants. Then out of 298 subjects, 277 subjects with AV Synchrony data available to define endpoint success were included.

The secondary safety endpoint evaluated a 3-month Atrial LP related complication-free rate based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications.

The primary analysis population for the secondary safety endpoint was based on subjects in the full analysis population, which included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.

The secondary safety endpoint analysis evaluated the 12-month Atrial LP related complication-free rate (CFRA) based on CEC adjudication of adverse events. An Atrial LP complication was defined as an atrial device-or-procedure-related serious adverse event. Complications that were exclusively related to the Ventricular LP or its delivery/retrieval were not considered Atrial LP complications and were excluded from the evaluation. For a conservative approach, complications that could not exclusively be determined to be related to the ventricular or Atrial LP were still considered Atrial LP complications. For example, procedure-related femoral access complications were adjudicated as Atrial LP complications. Complications possibly related or related to COVID-19 were excluded.

The analysis population for the secondary safety endpoint was based on subjects in the full analysis population, which included the first 300 consecutive de novo subjects who provided written informed consent and had an attempted implant.

Appropriate and proportional rate response of the Aveir Atrial Leadless Pacemaker in de novo subjects was tested during staged exercise testing. Exercise test data provided an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit and expresses it from 0-1.0. Since both axes are normalized sensor rate and workload, there is no distinct unit of measure. Values on the vertical axis are derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload. A slope value of 1.0 indicates the pacemaker's sensor-indicated rate increases linearly with an increase in workload.

Subjects with Analyzable CAEP Data