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

Biotronik SE & Co. KG88 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Arrhythmias, Cardiac

Interventions

SIELLO JT/TDEVICE

Implantation of SIELLO and BPPU pacemaker leads

Pacemaker therapyDEVICE

Pacemaker therapy

BPPU JT/TDEVICE

Implantation of SIELLO and BPPU pacemaker leads

Eligibility

Sex: ALLMin age: 18 Years

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)

Semmelweis University

Budapest, Hungary

Data from ClinicalTrials.gov

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