MATRIX

Management and Detection of Atrial Tachyarrhythmia in Patients Implanted With BIOTRONIK DX Systems

Multicenter, international, non-controlled, prospective, non-randomized registry
This study aims to collect data on efficacy and safety of the single-chamber BIOTRONIK DX system with enhanced atrial diagnostics
2000 patients planned - This study is ongoing

1° Endpoints	Frequency and type of AF-related complications Time to occurrence of first AF-related complication Time to AF-related intervention after detection of de novo AF or worsening AF
2° Endpoints	Frequency and type of complications related to implantations Frequency and type of lead-related complications All-cause mortality Cardiovascular hospitalization with days in hospital Significance of AF in acute decompensation of HF
Clinical Sites	126 centers planned
Sample Size	2000 patients planned
Inclusion Criteria	Indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines Implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment Written informed consent, willingness and ability to comply with the protocol
Main Exclusion Criteria	Age < 18 years Any limitation to contractual capability Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment Simultaneous participation in another study Life expectancy < 2 years
Devices	ICD DX devices and DX leads
Follow-Up	2 years
Study Duration	5 years - planned
Reference no.	NCT01774357
Principal Investigators	Prof. Dr. Gerhard Hindricks, Herzzentrum Leipzig, Germany

The DX system offers complete atrial diagnostics in a single–lead ICD device, encompassing the benefits of both single and dual-chamber ICDs.