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

Launched by BIOTRONIK SE & CO. KG · Jan 23, 2013

Keywords

ClinConnect Summary

Enrollment (E0)

Timing:

• 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.

Procedures:

* Check inclusion and exclusion criteria
* Patient information and written informed consent process
* Assignment of a unique study code
* ICD interrogation (re-programming if necessary)
* HMSC registration (recommended)
* Investigator assessment: appro...

Gender

ALL

Eligibility criteria

• 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
• 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