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

Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01000532

Enrollment

Registered

2009-10-23

Start date

2009-10-31

Completion date

2011-02-28

Last updated

2011-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac

Keywords

steroid, leads, threshold, pacemaker

Brief summary

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.

Interventions

DEVICESIELLO JT/T

Implantation of SIELLO and BPPU pacemaker leads

DEVICEPacemaker therapy

Pacemaker therapy

DEVICEBPPU JT/T

Implantation of SIELLO and BPPU pacemaker leads

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026