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CompletedNCT01000532Updated Nov 16, 2011

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

An observational study in Arrhythmias, Cardiac, sponsored by Biotronik SE & Co. KG. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-16.

Sponsored by Biotronik SE & Co. KG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
88
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arrhythmias, Cardiac

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Keywords

  • steroid, leads, threshold, pacemaker
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's enrollment of 88 is below the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
88 participants (actual)

Groups and cohorts

  • Pacemaker therapy

    Device: SIELLO JT/T · Device: Pacemaker therapy · Device: BPPU JT/T

Interventions

  • DeviceSIELLO JT/T

    Implantation of SIELLO and BPPU pacemaker leads

    Also known as: BPPU JT/T

  • DevicePacemaker therapy

    Pacemaker therapy

  • DeviceBPPU JT/T

    Implantation of SIELLO and BPPU pacemaker leads

06

Study locations

1 site
  • Semmelweis University
    Budapest, Hungary
07

References and documents

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 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01000532
Lead sponsor
Biotronik SE & Co. KG
Responsible party
Sponsor
First posted
Oct 23, 2009
Start date
Oct 2009
Primary completion
Sep 2010
Completion
Feb 2011
Last update
Nov 16, 2011

Study contacts

Béla Merkely, Professor
principal investigator · Semmelweis University Heart Center, Budapest, Hungary

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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