Trial results for the BIO|CONCEPT.Amvia Study, evaluating the Amvia/Solvia pacemaker family in patients with Heart Failure and bradycardia, were posted on ClinicalTrials.gov on 2025-07-24. The study reported that all 52 participants were free from serious adverse device effects after 12 months.
Background
Heart failure is a chronic condition where the heart cannot pump enough blood to meet the body's needs. Often, patients with heart failure may also experience bradycardia, a slower-than-normal heart rate, which can further exacerbate symptoms and impact quality of life. Pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) are crucial implantable devices designed to regulate heart rhythm and improve cardiac function in these patients. The development of new pacemaker technologies aims to enhance safety, performance, and patient outcomes, making the evaluation of preliminary safety and product performance a critical step in their clinical adoption.
Trial design
This completed exploratory study, designated as Phase NA, enrolled 52 participants with Bradycardia and Heart Failure. The trial's objective was to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family, specifically the Amvia Sky Pacemaker or CRT-P Implantation. Participants were followed at enrollment, implantation, pre-hospital discharge, and at 1-, 3-, and 12-month follow-up visits, during which device interrogation and standard measurements were performed. The study was conducted at sites in Australia and New Zealand.
Key results
The trial results highlighted several key measurements related to the safety and performance of the Amvia Sky Pacemaker or CRT-P Implantation:
- Serious Adverse Device Effect (SADE)-Free Rate After 12 Months: All 52 participants (100%) were free from serious adverse device effects.
- Right Atrial Sensing Amplitude: The mean amplitude was 3.4 mV with a standard deviation of 1.9.
- Right Atrial Pacing Threshold: The mean threshold was 0.9 V with a standard deviation of 0.7.
- Right Ventricular Sensing Amplitude: The mean amplitude was 10.8 mV with a standard deviation of 3.9.
- Right Ventricular Pacing Threshold: The mean threshold was 0.9 V with a standard deviation of 0.3.
- Left Ventricular Sensing Amplitude: The mean amplitude was 11.5 mV with a standard deviation of 6.0.
- Left Ventricular Pacing Threshold: The mean threshold was 1.4 V with a standard deviation of 0.5.
What this means
The posted results indicate a favorable preliminary safety profile for the Amvia Sky Pacemaker or CRT-P family, with all 52 participants remaining free from serious adverse device effects over 12 months. The reported sensing amplitudes and pacing thresholds across the right atrium, right ventricle, and left ventricle fall within expected physiological ranges for effective cardiac pacing. These performance metrics suggest that the device is functioning as intended in maintaining appropriate cardiac rhythm and output. For patients with heart failure and bradycardia, these findings support the potential for the Amvia/Solvia pacemaker family to provide safe and effective cardiac support, which is crucial for managing their condition and improving their quality of life.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05610176, titled "BIO|CONCEPT.Amvia Study", were posted on 2025-07-24 on clinicaltrials.gov.