NCT06018818

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2025

Completed
Last Updated

August 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

July 17, 2023

Last Update Submit

August 22, 2025

Conditions

BradycardiaHeart Failure

Outcome Measures

Primary Outcomes (1)

  • SADE-free rate at 6 months

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

    6 months

Secondary Outcomes (9)

  • SADE-free rate at 12 months

    12 months

  • CRT AutoAdapt performance

    12 months

  • CRT AutoAdapt AV delay

    12 months

  • Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator

    12 months

  • Auto LV VectorOpt

    12 months

  • +4 more secondary outcomes

Study Arms (1)

Amvia pacemaker or CRT-P implantation

OTHER
Device: Amvia/Solvia pacemaker family

Interventions

Amvia/Solvia pacemaker familyDEVICE

Implantation of a pacemaker or CRT-P devices

Amvia pacemaker or CRT-P implantation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kepler Universitätsklinikum

Linz, Austria

Location

Elisabeth-Krankenhaus Essen

Essen, Germany

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany

Location

MeSH Terms

Conditions

BradycardiaHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Istvan Szendey, Dr.

    Kliniken Maria Hilf GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 31, 2023

Study Start

August 23, 2023

Primary Completion

July 21, 2025

Study Completion

July 21, 2025

Last Updated

August 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)AU(1)