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ACTIVE NOT RECRUITING
NCT04869527

Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.

Sponsor: Biotronik SE & Co. KG

View on ClinicalTrials.gov

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

Interventions

DEVICE

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