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

NCT01000532 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2011-11-16

No results posted yet for this 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.

Conditions

  • Arrhythmias, Cardiac

Interventions

DEVICE

SIELLO JT/T

Implantation of SIELLO and BPPU pacemaker leads

DEVICE

Pacemaker therapy

Pacemaker therapy

DEVICE

BPPU JT/T

Implantation of SIELLO and BPPU pacemaker leads

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Béla Merkely, Professor · Semmelweis University Heart Center, Budapest, Hungary

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-09-30
Completion
2011-02-28

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01000532 on ClinicalTrials.gov