Safety and Performance Study of the Siello S Pacing Lead

Stopped early

Conditions studied: Safety and Effectiveness of the Siello S Lead

In brief

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

Key facts

Study ID

NCT01791127

Run by

Biotronik, Inc.

People needed

1758

Starts

2013-03-13

Expected to finish

2019-04-17

Last updated by the study team

2020-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — La Mesa, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Stamford, Connecticut, United States
• Study site — Plantation, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Cumming, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Jerseyville, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Grand Blanc, Michigan, United States
• Study site — Warren, Michigan, United States
• Study site — Ypsilanti, Michigan, United States
• Study site — Tupelo, Mississippi, United States
• Study site — Cape Girardeau, Missouri, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Bridgewater, New Jersey, United States
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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