N/A
Completed N=110
BIO|CONCEPT.Renamic Neo Study
Medical Devices
Source: ClinicalTrials.gov NCT04350008 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases — 0 use cases for Renamic Neo
Summary
The BIO|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patient is planned for de novo implantation or already has a BIOTRONIK active, implantable device.
- Patient is able to understand the nature of the study and provides written informed consent.
Exclusion Criteria
- Patient is implanted with a Stratos pacemaker.
- Patient is planned for implant exchange or upgrade.
- Patient is pregnant or breast feeding.
- Patient is less than 18 years old.
Data sourced from ClinicalTrials.gov (NCT04350008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.