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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01000532
First received: October 21, 2009
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Arrhythmias, Cardiac
 Device: SIELLO JT/T
Device: Pacemaker therapy
Device: BPPU JT/T

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Further study details as provided by Biotronik SE & Co. KG:

Enrollment: 88
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pacemaker therapy Device: SIELLO JT/T
Implantation of SIELLO and BPPU pacemaker leads
Other Names:
  • SIELLO JT/T
  • BPPU JT/T
Device: Pacemaker therapy
Pacemaker therapy
Device: BPPU JT/T
Implantation of SIELLO and BPPU pacemaker leads

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with standard pacemaker indication who are refered to the hospital.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000532

Locations
Hungary
Semmelweis University
Budapest, Hungary
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Béla Merkely, Professor Semmelweis University Heart Center, Budapest, Hungary
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01000532     History of Changes
Other Study ID Numbers: 47-1
Study First Received: October 21, 2009
Last Updated: November 15, 2011
Health Authority: Germany: Freiburger Ethikkommission International

Keywords provided by Biotronik SE & Co. KG:
steroid, leads, threshold, pacemaker

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013