Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT03366545
• Date of registration: 27/11/2017
• Prospective Registration: Yes
• Primary sponsor: Biotronik SE & Co. KG
• Public title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices BIO|STREAM HF
• Scientific title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
• Date of first enrolment: May 14, 2018
• Target sample size: 3000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03366545
• Study type: Observational [Patient Registry]

Countries of recruitment

Australia, Austria, Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Malaysia, Poland, Portugal, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, United Kingdom

Contacts

• Name: Maria Jung, Dr.

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: Cardiac Resynchronization Therapy (CRT)

Primary Outcome(s)

Number of patient deaths with cardiovascular cause [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Number of patients with cerebrovascular events [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Assessment of patients benefit from CRT [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Number of all adverse device effects [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Number of all device deficiencies [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Documentation of LVEF [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Number of patient deaths [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Documentation of LVESV [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Number of cardiovascular adverse events [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Number of all cause hospitalization [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Number of patients with worsening of heart failure events [Time Frame: throughout study duration, average of 3.5 years; annual evaluations]

Secondary ID(s)

CR021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors