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

Biotronik SE & Co. KG164 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Cardiac Pacemaker Syndrome

Interventions

Pacemaker therapyDEVICE

Implantation of the SIELLO pacemaker leads

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Allgemeines Krankenhaus Hamburg Altona

Hamburg, Germany

Outcomes

Primary Outcomes

Complication free rate of all SIELLO leads

Time frame: 3 month follow-up visits

Ventricular threshold of SIELLO T (passive fixation)

Time frame: 3 month follow-up visits

Atrial threshold of SIELLO S (active fixation)

Time frame: 3 month follow-up visits

Data from ClinicalTrials.gov

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