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Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
Sponsor: Biotronik SE & Co. KG
Summary
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs. Effects of the DX technology on related events, such as delivery of therapies and medical management, including eventual complications. Extended benefits offered by DX devices when associated with daily remote monitoring, by means of BIOTRONIK's Home Monitoring Service Center (HMSC).
Official title: Simplifying Access to Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Continuous Home Monitoring in Brazil
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2021-10-05
Completion Date
2025-04-30
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
BIOTRONIK ICDs with DX Technology
The BIOTRONIK DX system offers a single chamber ICD that enables sensing of atrial signals through floating atrial dipoles, using a single ventricular lead. This technology enables enhanced arrhythmia diagnosis based on atrial and ventricular electrograms and, in addition, early diagnosis and automatic transmission of AF and heart failure (HF) diagnostic data. The DX technology provides several features in a single chamber device that are usually only found in dual chamber devices, including atrial diagnostics and SVT discrimination - early detection of SAF, increased diagnostics accuracy, dual-chamber discrimination. Nevertheless, the benefits of a single chamber device are preserved: reduced lead complications, reduced procedure complexity, elimination of costs for atrial lead. The DX system also integrates with BIOTRONIK Home Monitoring, allowing physicians to remotely follow their patients' clinical and device statuses with daily updates.
Locations (2)
Santa Casa de Misericórdia de Porto Alegre - Brugada Institute
Porto Alegre, Rio Grande do Sul, Brazil
BIOTRONIK Coml Médica LTDA
São Paulo, Brazil