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

NCT06018818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Amvia/Solvia pacemaker family

Implantation of a pacemaker or CRT-P devices

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Istvan Szendey, Dr. · Kliniken Maria Hilf GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2025-07-21
Completion
2025-07-21

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06018818 on ClinicalTrials.gov