Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Amvia pacemaker or CRT-P implantation
|
Device: Amvia/Solvia pacemaker family
Implantation of a pacemaker or CRT-P devices
|
Outcome Measures
Primary Outcome Measures
- SADE-free rate at 6 months [6 months]
Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
Secondary Outcome Measures
- SADE-free rate at 12 months [12 months]
Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months
- CRT AutoAdapt performance [12 months]
CRT AutoAdapt: different pacing percentages
- CRT AutoAdapt AV delay [12 months]
Mean adapted AV delay after pace/sense
- Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator [12 months]
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
- Auto LV VectorOpt [12 months]
Time needed for threshold measurement
- Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator [2 months]
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
- aATP-related ADEs and SADEs [12 months]
aATP-related ADEs and SADEs
- Sensing performance of device-based measurements [12 months]
The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.
- Pacing performance of device-based measurements [12 months]
The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Biotronik SE & Co. KG
Investigators
- Principal Investigator: Istvan Szendey, Dr., Kliniken Maria Hilf GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BA114