Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 2,054
- Locations
- 1
- Primary Endpoint
- Frequency and types of AF-related complications
Study Overview
Brief Summary
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.
Detailed Description
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: appropriate atrial sensing
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Frequency and types of AF-related complications
Time Frame: 24 months
Time to occurrence of first AF-related complication
Time Frame: 24 months
Time to AF-related intervention after detection of de novo or worsening AF
Time Frame: 24 months
Secondary Outcomes
- All-cause mortality(24 months)
- Frequency and type of complications related to implantation(24 months)
- Significance of AF in acute decompensation of heart failure(24 months)
- Interventions based on Home Monitoring information regarding AF(24 months)
- Cardiovascular hospitalization with days in hospital(24 months)
- Frequency and type of lead-related complications(24 months)