ICD IndicationPhase 4NCT01090401
Linox Smart S DX PME/Master Study
A Phase 4 study testing Linox smart S DX in people with ICD Indication, run by Biotronik SE & Co. KG at 1 site in Germany.
Trial summary
The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD Indication
- What is being tested?
- Linox smart S DX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Oct 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Patients with standard ICD indication
- Be available for follow-up visits on a regular basis at an approved investigational center
Who cannot join
- Patients with standard ICD contra-indication
- Patients with permanent atrial fibrillation
- Have a life expectancy of less than six months
- Are expecting to receive cardiac surgery within 6 months after enrollment
- Age < 18 years
- Not enrolled in another cardiac clinical investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PME/Master Study of the Linoxsmart S DX ICD Leads
The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.
- Conditions
- ICD Indication
- Being tested
- Linox smart S DX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linox smart S DXDevice
ICD lead
| Study group | Role | What they receive |
|---|---|---|
| Patients with Linox smart S DX lead | Experimental | Not described Receives: Device: Linox smart S DX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of atrial adequate sensing
Measured: 6 months
Secondary outcomes (1)
Linox smart S DX related complication-free rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICD IndicationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
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
- NCT01090401
- Sponsor's protocol ID
- 48-1
- Status last verified
- Nov 2011
- First submitted
- 18 Mar 2010
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PME/Master Study of the Linoxsmart S DX ICD Leads
- ClinicalTrials.gov ID
- NCT01090401
- Acronym / sponsor ID
- 48-1
- Conditions
- ICD Indication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Mar 2010 (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 prove the safety and efficacy of the Linox smart S DX ICD lead.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Linox smart S DX lead | Experimental | Device: Linox smart S DX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with standard ICD indication
- Be available for follow-up visits on a regular basis at an approved investigational center
Key exclusion criteria (6 listed)
- Patients with standard ICD contra-indication
- Patients with permanent atrial fibrillation
- Have a life expectancy of less than six months
- Are expecting to receive cardiac surgery within 6 months after enrollment
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linox smart S DXICD lead | Device | Patients with Linox smart S DX lead |
Primary outcome
Rate of atrial adequate sensing
Time frame: 6 months
1 secondary outcome
Linox smart S DX related complication-free rate
Time frame: 6 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 16 Nov 2011.
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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?
A Phase 4 study testing Linox smart S DX in people with ICD Indication, 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 2 inclusion and 6 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 16 Nov 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 atrial adequate sensing (time frame: 6 months). 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 16 Nov 2011.