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

Arrhythmias, Cardiac Clinical Trial

Official title:

Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000532
• Other study ID #: 47-1
• Status: Completed
• Phase: N/A
• First received: October 21, 2009
• Last updated: November 15, 2011
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Freiburger Ethikkommission International
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Hungary,