BIO|CONCEPT.Renamic Neo Study

Biotronik

Status: Completed

Conditions: Medical Devices

Treatments: Device: Renamic Neo programmer device, including software; PK-222-L ECG cable

Study type: Observational

Funder types: Industry

Identifiers

NCT04350008

BA112

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design