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

Cardiac Pacemaker Syndrome Clinical Trial

Official title:

Master Study of the SIELLO Pacemaker Leads

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943046
• Other study ID #: 43-1
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2017
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A 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

Related Conditions & MeSH terms

• Cardiac Pacemaker Syndrome

Intervention

Device:
• Pacemaker therapy
Implantation of the SIELLO pacemaker leads

Locations

Country	Name	City	State
Germany	Allgemeines Krankenhaus Hamburg Altona	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication free rate of all SIELLO leads		3 month follow-up visits
Primary	Ventricular threshold of SIELLO T (passive fixation)		3 month follow-up visits
Primary	Atrial threshold of SIELLO S (active fixation)		3 month follow-up visits