Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems (MATRIX)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months. All analyses on the data will be done post-hoc; the study does not intend to confirm any pre-specified hypotheses.
• The enrollment (date of patient written informed consent) starts after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system according to current guidelines (primary or secondary prevention) but should not be later than 90 days after implantation.
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Patient information and written informed consent process
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with an indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines and after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment
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
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