BradycardiaNCT02059629
Eluna Family / Sentus BP Master Study
An observational study of Bradycardia and Heart Failure, run by Biotronik SE & Co. KG at 17 sites in 5 countries.
Trial summary
The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead. Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Heart Failure
- What is being tested?
- Eluna pacemaker family and Sentus BP lead
- Type of treatment
- Medical device
- How many people
- 167 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Feb 2014to Apr 2016
- 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 will be recruited from available pacemaker or CRT patients directly by the treating physician at the investigational site
Who may be able to join
- Patient is willing to participate in the study and provided written informed consent
- Patient meets standard indication for pacemaker or CRT-P or CRT-D therapy
- Patient accepts Home Monitoring® concept
- Patient has legal capacity and ability to consent
Who cannot join
- Patient with any contraindication to pacemaker and CRT-P and CRT-D therapy
- Patient under the age of 18
- Pregnant or breast-feeding women
- Cardiac surgery planned within the next 6 months
- Life expectancy less than 12 months
- Participation in another cardiac clinical investigation with active treatment arm
- Group B only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead (for CRT implants only)
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Germany10 sites
Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin
Berlin, 12203
Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum
Berlin, 13353
Klinikum Lippe
Detmold, 32756
Universitätsklinikum Erlangen, Medizinische Klinik 2
Erlangen, 91054
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
Essen, 45122
Elisabeth Krankenhaus Essen
Essen, 45138
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau, 79106
Universitätsmedizin Greifswald
Greifswald, 17475
St. Marien-Hospital Lünen
Lünen, 44534
Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis
Saarlouis, 66740
Denmark3 sites
Aalborg Sygehus
Aalborg, 9000
Gentofte Hospital
Hellerup, 2900
Odense University Hospital
Odense, 5000
About this study
The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.
Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.
- Conditions
- Bradycardia, Heart Failure
- Being tested
- Eluna pacemaker family, Sentus BP lead
- Keywords
- Heart failure, Eluna pacemaker family, Sentus OTW BP L left ventricular lead, Bradycardia, SADE-free rate
- Medical subject headings
- Bradycardia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eluna pacemaker familyDevice
Also called Eluna SR-T/DR-T/HF-T, Etrinsa SR-T/DR-T/HF-T, Epyra SR-T/DR-T/HF-T
New pacemaker generation with new functions, like wandless RF telemetry "SafeSync"
Sentus BP leadDevice
Also called Sentus OTW BP L
over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead
| Study group | Role | What they receive |
|---|---|---|
| Group A: Eluna pacemaker family | Patients with standard indication for pacemaker therapy or Cardiac Resynchronization Therapy (CRT), who will be implanted with a pacemaker or CRT device of the Eluna pacemaker family. Single-, Dual- and Tripple-chamber pacemakers are applicable. Receives: Device: Eluna pacemaker family | |
| Group B: Sentus BP lead | Heart failure patients with indication for Cardiac Resynchronization Therapy (CRT) therapy, who will be implanted with the left ventricular Sentus BP lead. Patients can receive either CRT pacemaker or CRT-D (CRT with defibrillator function). Receives: Device: Sentus BP lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate
The safety of the Eluna pacemaker family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.
Measured: 6 months
Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate
The safety of the Sentus BP left ventricular lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the Sentus BP lead will be the basis for endpoint calculation of the SADE free 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 posted11 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georges Mairesse, Dr. med, Principal investigator, Cliniques du Sud Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059629
- Sponsor's protocol ID
- CR014
- Status last verified
- May 2016
- First submitted
- 7 Feb 2014
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eluna Family / Sentus BP Master Study
- ClinicalTrials.gov ID
- NCT02059629
- Acronym / sponsor ID
- CR014
- Conditions
- Bradycardia, Heart Failure
- Keywords
- Heart failure, Eluna pacemaker family, Sentus OTW BP L left ventricular lead, Bradycardia, SADE-free rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Feb 2014 (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 Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.
Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Eluna pacemaker family | – | Device: Eluna pacemaker familyPatients with standard indication for pacemaker therapy or Cardiac Resynchronization Therapy (CRT), who will be implanted with a pacemaker or CRT device of the Eluna pacemaker family. Single-, Dual- and Tripple-chamber pacemakers are applicable. |
| Group B: Sentus BP lead | – | Device: Sentus BP leadHeart failure patients with indication for Cardiac Resynchronization Therapy (CRT) therapy, who will be implanted with the left ventricular Sentus BP lead. Patients can receive either CRT pacemaker or CRT-D (CRT with defibrillator function). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from available pacemaker or CRT patients directly by the treating physician at the investigational site
Key inclusion criteria (4 listed)
- Patient is willing to participate in the study and provided written informed consent
- Patient meets standard indication for pacemaker or CRT-P or CRT-D therapy
- Patient accepts Home Monitoring® concept
- Patient has legal capacity and ability to consent
Key exclusion criteria (7 listed)
- Patient with any contraindication to pacemaker and CRT-P and CRT-D therapy
- Patient under the age of 18
- Pregnant or breast-feeding women
- Cardiac surgery planned within the next 6 months
- Life expectancy less than 12 months
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 |
|---|---|---|
| Eluna pacemaker familyAlso: Eluna SR-T/DR-T/HF-T, Etrinsa SR-T/DR-T/HF-T, Epyra SR-T/DR-T/HF-TNew pacemaker generation with new functions, like wandless RF telemetry "SafeSync" | Device | Group A: Eluna pacemaker family |
| Sentus BP leadAlso: Sentus OTW BP Lover-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead | Device | Group B: Sentus BP lead |
Primary outcome
Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate
Time frame: 6 months
The safety of the Eluna pacemaker family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.
Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate
Time frame: 3 months
The safety of the Sentus BP left ventricular lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the Sentus BP lead will be the basis for endpoint calculation of the SADE free rate.
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 24 May 2016.
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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.
Georges Mairesse, Dr. med principal investigator
Cliniques du Sud Luxembourg
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Heart Failure, run by Biotronik SE & Co. KG at 17 sites in 5 countries.
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 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Denmark, Belgium, Austria, Hong Kong. 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?
Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate (time frame: 6 months). The study lists 2 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 24 May 2016.