Status:
RECRUITING
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT03366545
Start Date
May 14 2018
End Date
March 1 2026
Last Update
November 25 2024
Active Locations (121)
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1
Canberra Heart Rhythm Foundation
Canberra, Australia
2
The Canberra Hospital
Canberra, Australia
3
Lyell McEwin Hospital
Elizabeth Vale, Australia
4
Liverpool Hospital
Liverpool, Australia