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

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT03366545
• Lead Sponsor: Biotronik SE & Co. KG

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-08
• Study Start: 2018-05-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patient deaths	throughout study duration, average of 3.5 years; annual evaluations	Number of all-cause mortality
Number of patients with cerebrovascular events	throughout study duration, average of 3.5 years; annual evaluations	Number of cerebrovascular events requiring hospitalization
Assessment of patients benefit from CRT	throughout study duration, average of 3.5 years; annual evaluations	Documentation of NYHA classification \[I-IV\]
Documentation of LVEF	throughout study duration, average of 3.5 years; annual evaluations	Left ventricular ejection fraction \[%\]
Number of cardiovascular adverse events	throughout study duration, average of 3.5 years; annual evaluations	Number of unplanned hospitalization for cardiovascular cause
Number of patients with worsening of heart failure events	throughout study duration, average of 3.5 years; annual evaluations	Number of unplanned hospitalization for worsening of heart failure
Number of all adverse device effects	throughout study duration, average of 3.5 years; annual evaluations	Number of all adverse device effects
Number of patient deaths with cardiovascular cause	throughout study duration, average of 3.5 years; annual evaluations	Number of patient deaths with cardiovascular cause
Number of all cause hospitalization	throughout study duration, average of 3.5 years; annual evaluations	Number of all cause hospitalization
Number of all device deficiencies	throughout study duration, average of 3.5 years; annual evaluations	Number of all device deficiencies
Documentation of LVESV	throughout study duration, average of 3.5 years; annual evaluations	Left ventricular end-systolic volume \[ml\]

Trial Locations

Locations (121)

Canberra Heart Rhythm Foundation; 🇦🇺 Canberra, Australia

The Canberra Hospital; 🇦🇺 Canberra, Australia

Lyell McEwin Hospital; 🇦🇺 Elizabeth Vale, Australia

Liverpool Hospital; 🇦🇺 Liverpool, Australia

Sydney Adventist Hospital; 🇦🇺 Sydney, Australia

Westmead Hospital; 🇦🇺 Westmead, Australia

Westmead Private Hosptial; 🇦🇺 Westmead, Australia

Kepler Universitätsklinikum; 🇦🇹 Linz, Austria

Universitätsklinikum St. Pölten; 🇦🇹 St. Polten, Austria

Medizinische Universität Wien; 🇦🇹 Vienna, Austria

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