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

Arrhythmias, Cardiac Clinical Trial

Official title:
Simplifying Access to Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Continuous Home Monitoring in Brazil

Clinical Trial 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).

Clinical Trial Description

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). Primary Endpoint: - First confirmed episode of AF or atrial flutter (AFL) or supraventricular tachycardia (SVT), detected and transmitted to the HMSC. Other events of interest: - Rate of successful transmissions received and stored on the HMSC platform; - Hospital admissions related to cardiologic outcomes, at any time throughout the FU period; - A composite outcome of any of the following device-related complications: Need for any lead repositioning or replacement, pneumothorax, new pericardial effusion, tamponade, procedure-related death or wound infection, within 60 days after the ICD insertion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04869527
Study type Observational [Patient Registry]
Source Biotronik SE & Co. KG
Contact Luciano LC Carneiro, M.D., Ph.D.
Phone + 55 11 99424-1915
Email luciano.carneiro@biotronik.com
Status Recruiting
Phase
Start date October 5, 2021
Completion date April 2, 2025
View Details
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