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SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000532
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : November 16, 2011
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief 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.

Condition or disease Intervention/treatment
Arrhythmias, Cardiac Device: SIELLO JT/T Device: Pacemaker therapy Device: BPPU JT/T

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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)
Study Start Date : October 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
Pacemaker therapy Device: SIELLO JT/T
Implantation of SIELLO and BPPU pacemaker leads
Other Name: BPPU JT/T

Device: Pacemaker therapy
Pacemaker therapy

Device: BPPU JT/T
Implantation of SIELLO and BPPU pacemaker leads

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with standard pacemaker indication who are refered to the hospital.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01000532

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Semmelweis University
Budapest, Hungary
Sponsors and Collaborators
Biotronik SE & Co. KG
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Principal Investigator: Béla Merkely, Professor Semmelweis University Heart Center, Budapest, Hungary
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Biotronik SE & Co. KG Identifier: NCT01000532    
Other Study ID Numbers: 47-1
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011
Keywords provided by Biotronik SE & Co. KG:
steroid, leads, threshold, pacemaker
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes