Cardiac Pacemaker SyndromeNCT00943046
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads
A study testing Pacemaker therapy in people with Cardiac Pacemaker Syndrome, 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 SIELLO pacemaker leads. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Pacemaker Syndrome
- What is being tested?
- Pacemaker therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Dec 2010
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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: Master Study of the SIELLO Pacemaker Leads
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
Read the detailed description
The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.
- Conditions
- Cardiac Pacemaker Syndrome
- Being tested
- Pacemaker therapy
- Keywords
- leads, pacemaker, efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker therapyDevice
Implantation of the SIELLO pacemaker leads
| Study group | Role | What they receive |
|---|---|---|
| Siello pacemaker lead | Experimental | Patients with Siello Pacemaker lead Receives: Device: Pacemaker therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication free rate of all SIELLO leads
Measured: 3 month follow-up visits
Ventricular threshold of SIELLO T (passive fixation)
Measured: 3 month follow-up visits
Atrial threshold of SIELLO S (active fixation)
Measured: 3 month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Pacemaker SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anselm Schaumann, Dr., Principal investigator, n.k.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943046
- Sponsor's protocol ID
- 43-1
- Status last verified
- May 2017
- First submitted
- 14 Jul 2009
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study of the SIELLO Pacemaker Leads
- ClinicalTrials.gov ID
- NCT00943046
- Acronym / sponsor ID
- 43-1
- Conditions
- Cardiac Pacemaker Syndrome
- Keywords
- leads, pacemaker, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Jul 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.
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
Detailed description
The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siello pacemaker lead | Experimental | Device: Pacemaker therapyPatients with Siello Pacemaker lead |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 (4 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- Have other medical devices that may interact with the implanted pacemaker
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 |
|---|---|---|
| Pacemaker therapyImplantation of the SIELLO pacemaker leads | Device | Siello pacemaker lead |
Primary outcome
Complication free rate of all SIELLO leads
Time frame: 3 month follow-up visits
Ventricular threshold of SIELLO T (passive fixation)
Time frame: 3 month follow-up visits
Atrial threshold of SIELLO S (active fixation)
Time frame: 3 month follow-up visits
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 26 Jul 2019.
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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.
Anselm Schaumann, Dr. principal investigator
n.k.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker therapy in people with Cardiac Pacemaker Syndrome, 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 5 inclusion and 4 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 26 Jul 2019. 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?
Complication free rate of all SIELLO leads (time frame: 3 month follow-up visits). 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 26 Jul 2019.