Overview

This trial is active, not recruiting.

Condition safety and effectiveness of the siello s lead.
Treatment patients with a biotronik pacemaker system and one or two siello s leads.
Sponsor Biotronik, Inc.
Start date January 2013
End date January 2018
Trial size 1800 participants
Trial identifier NCT01791127, G110221

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients with a BIOTRONIK pacemaker system with one or two Siello S leads.
patients with a biotronik pacemaker system and one or two siello s leads.

Primary Outcomes

Measure
Atrial Siello S Lead Safety
time frame: 12 month
Ventricular Siello S Lead Safety
time frame: 12-month
Siello S Lead Effectiveness
time frame: 12-months
Siello S Lead Safety
time frame: 5-Years
Siello Ventricular Lead Safety
time frame: 5-years

Secondary Outcomes

Measure
Adverse Event-Free Rate for Secondary (RA) lead position
time frame: 5-years
Individual Adverse Event Rates for Secondary (RA) lead position
time frame: 5-years
Pacing threshold, sensing and impedance measurements for the atrial and ventricular Siello S leads
time frame: 12-months
Adverse event rates for adverse events excluded from primary endpoints
time frame: 5-years
Pacing threshold, sensing and impedance measurements for the Siello S lead
time frame: 5-years
Siello S Lead Effectiveness
time frame: 5-years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Biotronik, Inc..