NCT00943046

Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

Master Study of the SIELLO Pacemaker Leads

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

Detailed description

The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Conditions

• Cardiac Pacemaker Syndrome

Interventions

Type	Name	Description
DEVICE	Pacemaker therapy	Implantation of the SIELLO pacemaker leads

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-11-01
• Completion: 2010-12-01
• First posted: 2009-07-21
• Last updated: 2019-07-26

Locations

1 site across 1 country: Germany