Post Market Clinical Follow-up Study for the Amvia/Solvia... | NCT06018818

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

NCT06018818

Sponsor

Biotronik SE & Co. KG

Status

Completed

Last Update Posted

Aug 24, 2025Actual

Enrollment

129Actual

Phase

Not Applicable

Conditions

Bradycardia
Heart Failure

Interventions

Amvia/Solvia pacemaker family

Countries

Austria
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 23, 2023Actual

Primary Completion Date

Jul 21, 2025Actual

Completion Date

Jul 21, 2025Actual

First Submitted Date

Jul 17, 2023

First Submission Date that Met QC Criteria

Aug 29, 2023

First Posted Date

Aug 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2025

Last Update Posted Date

Aug 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

129Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amvia pacemaker or CRT-P implantation	Other		Device: Amvia/Solvia pacemaker family

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amvia/Solvia pacemaker family	Device	Implantation of a pacemaker or CRT-P devices	Amvia pacemaker or CRT-P implantation

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Istvan Szendey, Dr.	Kliniken Maria Hilf GmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kepler Universitätsklinikum		Linz			Austria
Elisabeth-Krankenhaus Essen

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 7, 2026

Condition Browse Module

MeSH Terms

ID	Term
D001919	Bradycardia
D006333	Heart Failure

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided