Biotronik announced that the MATRIX study has demonstrated the high detection accuracy of DX single-lead implantable cardioverter-defibrillator (ICD) systems for atrial fibrillation (AF) in single-chamber ICD patients.
The system, together with the company’s Home Monitoring solution, enabled the guideline-recommended remote monitoring of subclinical AF.
The trial assessed the ability of the DX-ICD system (atrial signal detection via a floating dipole integrated in the ICD lead) to remotely monitor atrial high-rate episodes (AHRE) and their duration progression.
Furthermore, the clinical implications of AHRE detection and progression were also evaluated as part of the study.
Biotronik chief medical officer David Hayes said: “As the largest clinical evaluation of the DX Technology to date, the MATRIX study has clearly proven, under real-world conditions, that DX-ICDs together with Biotronik Home Monitoring can provide clinically-relevant benefits that support physicians in making the right decisions for their single-chamber ICD patients – timely and consistent with current medical guidelines.”
The study was led by Gerhard Hindricks from Deutsches Herzzentrum der Charité and Andreas Bollmann from the Heart Center Leipzig at the University of Leipzig and Helios Health Institute, Germany.
The international and multicentre trial recruited 2,054 DX-ICD patients in 119 sites across 24 countries. Patients have been followed for two years under real-life conditions.
In a statement, Hindricks said: “Our analysis shows that you can detect and monitor AHRE with high accuracy in single-chamber ICD patients using DX Technology.
“Together with the proven transmission reliability of Home Monitoring, this supports a reliable AHRE burden monitoring, as recommended by current guidelines.”