Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

Study Overview
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Brief Summary
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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.

Official Title
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BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

Conditions
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Bradycardia, Heart Failure

Intervention / Treatment
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* Device: Amvia/Solvia pacemaker family


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation Ability to understand the nature of the study Willingness to provide written informed consent Ability and willingness to perform all follow-up visits at the study site Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept Exclusion Criteria: Planned for conduction system pacing Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months Known pregnancy or breast feeding Age less than 18 years Participation in another interventional clinical investigation Life-expectancy less than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Amvia pacemaker or CRT-P implantation<br> | Device: Amvia/Solvia pacemaker family<br>* Implantation of a pacemaker or CRT-P devices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SADE-free rate at 6 months | Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SADE-free rate at 12 months | Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months | 12 months | 
| CRT AutoAdapt performance | CRT AutoAdapt: different pacing percentages | 12 months | 
| CRT AutoAdapt AV delay | Mean adapted AV delay after pace/sense | 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) | 12 months | 
| Auto LV VectorOpt | Time needed for threshold measurement | 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) | 2 months | 
| aATP-related ADEs and SADEs | aATP-related ADEs and SADEs | 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. | 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. | 12 months |