An interventional study of Amvia/Solvia pacemaker family in Bradycardia and Heart Failure, sponsored by Biotronik SE & Co. KG. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Biotronik SE & Co. KG · Not applicable, Interventional, and Treatment
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.
307 studies on the registry are indexed under Bradycardia; 70 are open to participants now.
This study's enrollment of 129 is above the median of 98 across 175 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Amvia/Solvia pacemaker family
Implantation of a pacemaker or CRT-P devices
SADE-free rate at 6 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
Time frame: 6 months
SADE-free rate at 12 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months
Time frame: 12 months
CRT AutoAdapt performance
CRT AutoAdapt: different pacing percentages
Time frame: 12 months
CRT AutoAdapt AV delay
Mean adapted AV delay after pace/sense
Time frame: 12 months
Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
Time frame: 12 months
Auto LV VectorOpt
Time needed for threshold measurement
Time frame: 12 months
Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
Time frame: 2 months
aATP-related ADEs and SADEs
aATP-related ADEs and SADEs
Time frame: 12 months
Sensing performance of device-based measurements
The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.
Time frame: 12 months
Pacing performance of device-based measurements
The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Biotronik SE & Co. KG