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
  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:


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
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, see Learn About Clinical Studies.

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 by Biotronik SE & Co. KG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014