Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices (BIO|STREAM HF)

Biotronik

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: Cardiac Resynchronization Therapy (CRT)

Study type: Observational

Funder types: Industry

Identifiers

NCT03366545

CR021

Details and patient eligibility

About

The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned de novo implantation of or upgrade to a CRT system for treatment according to the intended use
• Patient is able to understand the nature of the registry and has provided written informed consent
• Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept
• Remote monitoring using the Home Monitoring® platform is planned for the patient

Exclusion criteria

• Standard contraindication for CRT
• Already or previously implanted with CRT system
• • Age < 18 years
• Participation in another interventional clinical investigation other than the registry-based trials of BIO|STREAM.HF
• Pregnant or breastfeeding