Safety and Performance Study of the Siello S Pacing Lead

N/ATerminatedNCT01791127

Biotronik, Inc.1,758 enrolled

Overview

The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.

Study Type

OBSERVATIONAL

Enrollment

1,758

Conditions

Safety and Effectiveness of the Siello S Lead

Interventions

market-released BIOTRONIK pacemaker system including one or two Siello S leads.DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Candidate for de novo implantation of a BIOTRONIK pacemaker system, including one or two Siello S leads. Candidate meets recommendation for pacemaker system implant put forth by guidelines of relevant professional societies. * Able to understand the nature of the study and provide informed consent. * Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up. * Age greater than or equal to 18 years. Exclusion Criteria: * Enrolled in any other investigational clinical study. * Currently implanted with a pacemaker or ICD device. * Planned cardiac surgical procedures or interventional measures within the next 6 months. * Expected to receive a heart transplant within 1 year. * Life expectancy less than 1 year. * Presence of another life-threatening, underlying illness separate from their cardiac disorder. * Pregnant at the time of enrollment.

Locations (53)

Outcomes

Primary Outcomes

Atrial Siello S Lead Safety at 12 Months

The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).

Time frame: 12 month

Ventricular Siello S Lead Safety at 12 Months

The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).

Time frame: 12-month

Siello S Lead Effectiveness at 12 Months

Success rate of the implanted system to sense and deliver pacing at 12-months post implant.

Time frame: 12-months

Ventricular Siello S Lead Safety at 5 Years

The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).

Time frame: 5-Years

Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates

Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.

Time frame: 5-years

Secondary Outcomes

Atrial Siello S Lead Safety at 5 Years

The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Unnamed facility

La Jolla, California, United States

Unnamed facility

La Mesa, California, United States

Unnamed facility

New Haven, Connecticut, United States

Unnamed facility

Stamford, Connecticut, United States

Unnamed facility

Plantation, Florida, United States

Unnamed facility

St. Petersburg, Florida, United States

Unnamed facility

Cumming, Georgia, United States

Unnamed facility

Chicago, Illinois, United States

Unnamed facility

Jerseyville, Illinois, United States

Unnamed facility

Park Ridge, Illinois, United States

...and 43 more locations