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

Completed

• Conditions: Arrhythmias, Cardiac
• Interventions: Device: SIELLO JT/T; Device: Pacemaker therapy; Device: BPPU JT/T

• Registration Number: NCT01000532
• Lead Sponsor: Biotronik SE & Co. KG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Primary Completion: 2010-09
• Study Completion: 2011-02
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pacemaker therapy	Pacemaker therapy	-
Pacemaker therapy	SIELLO JT/T	-
Pacemaker therapy	BPPU JT/T	-

Trial Locations

Locations (1)

Semmelweis University; 🇭🇺 Budapest, Hungary