Cardiac DiseaseNCT01486836
Lumax DX / Linox DX Evaluation
An observational study of Cardiac Disease, run by Biotronik SE & Co. KG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with standard ICD indication who are referred to the hospital.
Who may be able to join
- Patient meets the indication for ICD therapy
- LVEF ≥ 30%
- Patient's compliance with protocol
- Signed patient informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system.
No hypothesis has been defined.
- Conditions
- Cardiac Disease
- Keywords
- Cardiac disease (ICD indication)
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICD therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of appropriate atrial sensing
Measured: 3 months
Rate of successfully terminated tachyarrhythmia episodes
Measured: 3 months
Serious adverse device effect rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486836
- Sponsor's protocol ID
- 58
- Status last verified
- Sep 2013
- First submitted
- 15 Nov 2011
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)
- ClinicalTrials.gov ID
- NCT01486836
- Acronym / sponsor ID
- 58
- Conditions
- Cardiac Disease
- Keywords
- Cardiac disease (ICD indication)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with standard ICD indication who are referred to the hospital.
Key inclusion criteria (4 listed)
- Patient meets the indication for ICD therapy
- LVEF ≥ 30%
- Patient's compliance with protocol
- Signed patient informed consent form
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Biotronik SE & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of appropriate atrial sensing (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.