NCT01486836CompletedNot Applicable
Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Rate of appropriate atrial sensing
Study Overview
Brief Summary
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system.
No hypothesis has been defined.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient meets the indication for ICD therapy
- •LVEF ≥ 30%
- •Patient's compliance with protocol
- •Signed patient informed consent form
Exclusion Criteria
- •Patient meets one contraindication for ICD therapy
- •Permanent atrial tachyarrhythmia
- •Age < 18 years
- •Cardiac surgery planned within the next 6 months
- •Life expectancy of less than 6 months
- •Limited contractual capability
- •Participating in another clinical study of an investigational cardiac drug or device
Outcomes
Primary Outcomes
Rate of appropriate atrial sensing
Time Frame: 3 months
Rate of successfully terminated tachyarrhythmia episodes
Time Frame: 3 months
Serious adverse device effect rate
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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