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

Not Applicable

Active, not recruiting

• Conditions: Heart Failure; Bradycardia

• Registration Number: NCT06018818
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-17
• Study Start: 2023-08-23
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-08-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SADE-free rate at 6 months	6 months	Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months

Secondary Outcome Measures

Name	Time	Method
aATP-related ADEs and SADEs	12 months	aATP-related ADEs and SADEs
SADE-free rate at 12 months	12 months	Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months
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
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.
CRT AutoAdapt performance	12 months	CRT AutoAdapt: different pacing percentages
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)
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.

Trial Locations

Locations (3)

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

Elisabeth-Krankenhaus Essen; 🇩🇪 Essen, Germany

Kliniken Maria Hilf GmbH; 🇩🇪 Mönchengladbach, Germany