Lumax DX / Linox DX Evaluation
Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)
1 other identifier
observational
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 12, 2013
September 1, 2013
10 months
November 15, 2011
September 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of appropriate atrial sensing
3 months
Rate of successfully terminated tachyarrhythmia episodes
3 months
Serious adverse device effect rate
3 months
Study Arms (1)
ICD therapy
Eligibility Criteria
Patients with standard ICD indication who are referred to the hospital.
You may qualify if:
- Patient meets the indication for ICD therapy
- LVEF ≥ 30%
- Patient's compliance with protocol
- Signed patient informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité Uniklinikum Benjamin Franklin
Berlin, 12200, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2011
First Posted
December 7, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 12, 2013
Record last verified: 2013-09