Safety and Efficacy of the Lumax 740 ICD FamilyLumax 740NCT01454050
Lumax 740 Master Study
An observational study of Safety and Efficacy of the Lumax 740 ICD Family, 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 Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety and Efficacy of the Lumax 740 ICD Family
- How many people
- 189 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Nov 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
- Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.
- Legal capacity and ability to consent
- Signed patient informed consent
- In addition for HF-T devices:
- Bipolar LV-lead with a min. distance of 15 mm between tip and ring
- True bipolar RV lead
Who cannot join
- Standard contraindication for single, dual, or triple chamber ICD.
- Age < 18 years
- Pregnant or breast-feeding woman
- Cardiac surgery planned within the next 6 months
- Life expectancy of less than 6 months
- Participating in any other clinical study of an investigational cardiac drug or device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PME/Master Study of the Lumax 740 ICD Family
The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.
- Keywords
- ICD therapy, RV/LV Capture Control, Safety and Efficacy
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the automatic Capture Control feature
Measured: PHD, 1-, 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Efficacy of the Lumax 740 ICD FamilyStudies 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Klein, Prof. Dr., Study chair, Herz im Zentrum Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454050
- Sponsor's protocol ID
- 55
- Acronym
- Lumax 740
- Status last verified
- Nov 2012
- First submitted
- 14 Oct 2011
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PME/Master Study of the Lumax 740 ICD Family
- ClinicalTrials.gov ID
- NCT01454050
- Acronym / sponsor ID
- Lumax 740 / 55
- Keywords
- ICD therapy, RV/LV Capture Control, Safety and Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Oct 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 prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 (6 listed)
- Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.
- Bipolar LV-lead with a min. distance of 15 mm between tip and ring
- True bipolar RV lead
Key exclusion criteria (6 listed)
- Standard contraindication for single, dual, or triple chamber ICD.
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
Efficacy of the automatic Capture Control feature
Time frame: PHD, 1-, 3- and 6-month follow-up
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 28 Nov 2012.
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.
Gunnar Klein, Prof. Dr. study chair
Herz im Zentrum Hannover, Germany
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 Safety and Efficacy of the Lumax 740 ICD Family, 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 6 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 28 Nov 2012. 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?
Efficacy of the automatic Capture Control feature (time frame: PHD, 1-, 3- and 6-month follow-up). 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 28 Nov 2012.