Trials / Completed
CompletedNCT04350008
BIO|CONCEPT.Renamic Neo Study
BIO|CONCEPT.Renamic Neo
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (actual)
- Sponsor
- Biotronik Australia Pty Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Renamic Neo programmer device, including software; PK-222-L ECG cable | Patients were enrolled either for implantation including subsequent pre-hospital discharge or for a follow-up visit only. ICM patients were included for follow-ups only. Implants were programmed and interrogated by using the investigational devices. |
Timeline
- Start date
- 2020-06-08
- Primary completion
- 2020-10-29
- Completion
- 2020-10-29
- First posted
- 2020-04-16
- Last updated
- 2022-09-16
- Results posted
- 2022-09-16
Locations
8 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT04350008. Inclusion in this directory is not an endorsement.