NCT03366545 - Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices | Crick | Crick

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

N/AActive Not RecruitingNCT03366545

Biotronik SE & Co. KG3,030 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,030

Conditions

Interventions

Cardiac Resynchronization Therapy (CRT)DEVICE

Observation and documentation of routine care for CRT patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (114)

Outcomes

Primary Outcomes

Number of cardiovascular adverse events

Number of unplanned hospitalization for cardiovascular cause

Time frame: throughout study duration, average of 3.5 years; annual evaluations

Number of patient deaths

Number of all-cause mortality

Time frame: throughout study duration, average of 3.5 years; annual evaluations

Number of all cause hospitalization

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

Number of unplanned hospitalization for worsening of heart failure

Time frame: throughout study duration, average of 3.5 years; annual evaluations

Number of patients with cerebrovascular events

Number of cerebrovascular events requiring hospitalization

Time frame: throughout study duration, average of 3.5 years; annual evaluations

Number of all adverse device effects

Number of all adverse device effects

Time frame: throughout study duration, average of 3.5 years; annual evaluations

Number of all device deficiencies

Number of all device deficiencies

Time frame: throughout study duration, average of 3.5 years; annual evaluations

Assessment of patients benefit from CRT

Documentation of NYHA classification \[I-IV\]

Time frame: throughout study duration, average of 3.5 years; annual evaluations

Data from ClinicalTrials.gov

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