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

Active, not recruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

October 5, 2021

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2025

Conditions
Arrhythmias, Cardiac
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.

Trial Locations (2)

90020-090

Santa Casa de Misericórdia de Porto Alegre - Brugada Institute, Porto Alegre

01533-000

BIOTRONIK Coml Médica LTDA, São Paulo

All Listed Sponsors
collaborator

Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

lead

Biotronik SE & Co. KG

INDUSTRY

NCT04869527 - Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil. | Biotech Hunter | Biotech Hunter