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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018818
• Other study ID #: BA114
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: May 2025

Study information

• Verified date: August 2023
• Source: Biotronik SE & Co. KG
• Contact: Dörte Vossmeyer, Dr.
• Phone: +49 30 68905 1306
• Email: doerte.vossmeyer[@]biotronik.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure

Intervention

Device:
• Amvia/Solvia pacemaker family
Implantation of a pacemaker or CRT-P devices

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum	Linz
Germany	Elisabeth-Krankenhaus Essen	Essen
Germany	Kliniken Maria Hilf GmbH	Mönchengladbach

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SADE-free rate at 6 months	Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months	6 months
Secondary	SADE-free rate at 12 months	Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months	12 months
Secondary	CRT AutoAdapt performance	CRT AutoAdapt: different pacing percentages	12 months
Secondary	CRT AutoAdapt AV delay	Mean adapted AV delay after pace/sense	12 months
Secondary	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
Secondary	Auto LV VectorOpt	Time needed for threshold measurement	12 months
Secondary	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
Secondary	aATP-related ADEs and SADEs	aATP-related ADEs and SADEs	12 months
Secondary	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
Secondary	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