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

Not Applicable

Completed

• Conditions: Cardiac Pacemaker Syndrome
• Interventions: Device: Pacemaker therapy

• Registration Number: NCT00943046
• Lead Sponsor: Biotronik SE & Co. KG

Brief 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-20
• Study First Posted: 2009-07-21
• Primary Completion: 2009-11
• Study Completion: 2010-12
• Status Verified: 2017-05
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Siello pacemaker lead	Pacemaker therapy	Patients with Siello Pacemaker lead

Primary Outcome Measures

Name	Time	Method
Complication free rate of all SIELLO leads	3 month follow-up visits
Ventricular threshold of SIELLO T (passive fixation)	3 month follow-up visits
Atrial threshold of SIELLO S (active fixation)	3 month follow-up visits

Trial Locations

Locations (1)

Allgemeines Krankenhaus Hamburg Altona; 🇩🇪 Hamburg, Germany