Status:
COMPLETED
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Bradycardia
Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
NA
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, includ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2025
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT06018818
Start Date
August 23 2023
End Date
July 21 2025
Last Update
August 24 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Kepler Universitätsklinikum
Linz, Austria
2
Elisabeth-Krankenhaus Essen
Essen, Germany
3
Kliniken Maria Hilf GmbH
Mönchengladbach, Germany