Arrhythmias, CardiacNCT01000532
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads
An observational study of Arrhythmias, Cardiac, run by Biotronik SE & Co. KG at 1 site in Hungary.
Trial summary
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- SIELLO JT/T, Pacemaker therapy and BPPU JT/T
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteHungary
- Study dates
- Oct 2009to Feb 2011
- 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 pacemaker indication who are refered to the hospital.
Who may be able to join
- Meet the indications for pacemaker therapy
- Understand the nature of the procedure
- Give informed consent
- Able to complete all testing required by the clinical protocol
- Available for follow-up visits on a regular basis at the investigational site
Who cannot join
- Meet none of the pacemaker indications
- Meet one or more of the contraindications
- Have a life expectancy of less than six months
- Cardiac surgery in the next six months
- Enrolled in another cardiac clinical investigation
- Have other medical devices that may interact with the implanted pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- SIELLO JT/T, Pacemaker therapy, BPPU JT/T
- Keywords
- steroid, leads, threshold, pacemaker
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIELLO JT/TDevice
Also called BPPU JT/T
Implantation of SIELLO and BPPU pacemaker leads
Pacemaker therapyDevice
Pacemaker therapy
BPPU JT/TDevice
Implantation of SIELLO and BPPU pacemaker leads
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker therapy | Not described Receives: Device: SIELLO JT/T; Device: Pacemaker therapy; Device: BPPU JT/T |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Béla Merkely, Professor, Principal investigator, Semmelweis University Heart Center, Budapest, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000532
- Sponsor's protocol ID
- 47-1
- Status last verified
- Nov 2011
- First submitted
- 21 Oct 2009
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kutyifa V, Zima E, Molnar L, Kuehne C, Theiss S, Herrmann G, Geller L, Merkely B. Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial. Cardiol J. 2013;20(4):431-8. doi: 10.5603/CJ.2013.0103.
PubMed 23913463
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
- Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)
- ClinicalTrials.gov ID
- NCT01000532
- Acronym / sponsor ID
- 47-1
- Conditions
- Arrhythmias, Cardiac
- Keywords
- steroid, leads, threshold, pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Oct 2009 (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.
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker therapy | – | Device: SIELLO JT/T, Device: Pacemaker therapy, Device: BPPU JT/T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with standard pacemaker indication who are refered to the hospital.
Key inclusion criteria (5 listed)
- Meet the indications for pacemaker therapy
- Understand the nature of the procedure
- Give informed consent
- Able to complete all testing required by the clinical protocol
- Available for follow-up visits on a regular basis at the investigational site
Key exclusion criteria (6 listed)
- Meet none of the pacemaker indications
- Meet one or more of the contraindications
- Have a life expectancy of less than six months
- Cardiac surgery in the next six months
- Enrolled in another cardiac clinical investigation
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 |
|---|---|---|
| SIELLO JT/TAlso: BPPU JT/TImplantation of SIELLO and BPPU pacemaker leads | Device | Pacemaker therapy |
| Pacemaker therapyPacemaker therapy | Device | Pacemaker therapy |
| BPPU JT/TImplantation of SIELLO and BPPU pacemaker leads | Device | Pacemaker therapy |
Primary outcome
Not reported in the source record.
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.
- Derived from this study: PubMed 23913463Kutyifa V, Zima E, Molnar L, Kuehne C, Theiss S, Herrmann G, Geller L, Merkely B. Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial. Cardiol J. 2013;20(4):431-8. doi: 10.5603/CJ.2013.0103.
Related trials for Arrhythmias, Cardiac
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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.
Béla Merkely, Professor principal investigator
Semmelweis University Heart Center, Budapest, Hungary
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 Arrhythmias, Cardiac, run by Biotronik SE & Co. KG at 1 site in Hungary.
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 5 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 Hungary. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000532, which also lists 1 linked publication.
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.