Clinical trial NCT01791127: Safety and Performance Study of the Siello S Pacing Lead
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Safety and Effectiveness of the Siello S Lead
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 1758
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Atrial Siello S Lead Safety at 12 Months
timeFrame: 12 month
measure: Ventricular Siello S Lead Safety at 12 Months
timeFrame: 12-month
measure: Siello S Lead Effectiveness at 12 Months
timeFrame: 12-months
measure: Ventricular Siello S Lead Safety at 5 Years
timeFrame: 5-Years
measure: Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
timeFrame: 5-years
Secondary outcomes:
measure: Atrial Siello S Lead Safety at 5 Years
timeFrame: 5-years
measure: Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
timeFrame: 5-years
measure: Pacing Threshold Measurements for Siello S Leads at 12 Months
timeFrame: 12-months
measure: Sensing Measurements for Siello S Leads at 12 Months
timeFrame: 12-months
measure: Impedance Measurements for Siello S Leads at 12 Months
timeFrame: 12-months
measure: Percentage of Participants With Other Adverse Events
timeFrame: 5-years
measure: Siello S Lead Effectiveness at 5 Years
timeFrame: 5-years
measure: Pacing Threshold Measurements for Siello S Leads Through 5 Years
timeFrame: 5-years
measure: Sensing Measurements for Siello S Leads Through 5 Years
timeFrame: 5-years
measure: Impedance Measurements for Siello S Leads Through 5 Years
timeFrame: 5-years
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: La Mesa
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Stamford
country: United States
state: Connecticut
city: Plantation
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Cumming
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Jerseyville
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Valparaiso
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Grand Blanc
country: United States
state: Michigan
city: Warren
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Tupelo
country: United States
state: Mississippi
city: Cape Girardeau
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Bridgewater
country: United States
state: New Jersey
city: Haddon Heights
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: Concord
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Steubenville
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Lancaster
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Alice
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Orange
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Victoria
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fredericksburg
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Cheyenne
country: United States
state: Wyoming
Study officials:
References: