Safety and Performance Study of the Siello S Pacing Lead (SIELLO)

May 12, 2020 updated by: Biotronik, Inc.
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1758

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
      • La Mesa, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
      • Stamford, Connecticut, United States
    • Florida
      • Plantation, Florida, United States
      • Saint Petersburg, Florida, United States
    • Georgia
      • Cumming, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Jerseyville, Illinois, United States
      • Park Ridge, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Valparaiso, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
      • Grand Blanc, Michigan, United States
      • Warren, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Missouri
      • Cape Girardeau, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • Haddon Heights, New Jersey, United States
    • New York
      • Flushing, New York, United States
    • North Carolina
      • Concord, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Middletown, Ohio, United States
      • Steubenville, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Greenville, South Carolina, United States
      • Lancaster, South Carolina, United States
      • Rock Hill, South Carolina, United States
      • West Columbia, South Carolina, United States
    • Texas
      • Alice, Texas, United States
      • Bedford, Texas, United States
      • Orange, Texas, United States
      • San Antonio, Texas, United States
      • Victoria, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Fredericksburg, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
    • Wyoming
      • Cheyenne, Wyoming, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pacemaker Therapy
Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Atrial Siello S Lead Safety at 12 Months
Time Frame: 12 month
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).
12 month
Ventricular Siello S Lead Safety at 12 Months
Time Frame: 12-month
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).
12-month
Siello S Lead Effectiveness at 12 Months
Time Frame: 12-months
Success rate of the implanted system to sense and deliver pacing at 12-months post implant.
12-months
Ventricular Siello S Lead Safety at 5 Years
Time Frame: 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).
5-Years
Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Time Frame: 5-years
Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.
5-years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Atrial Siello S Lead Safety at 5 Years
Time Frame: 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).
5-years
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Time Frame: 5-years
Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.
5-years
Pacing Threshold Measurements for Siello S Leads at 12 Months
Time Frame: 12-months
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
12-months
Sensing Measurements for Siello S Leads at 12 Months
Time Frame: 12-months
Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
12-months
Impedance Measurements for Siello S Leads at 12 Months
Time Frame: 12-months
Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
12-months
Percentage of Participants With Other Adverse Events
Time Frame: 5-years
The overall percentage of subjects with reportable adverse events that were excluded from primary and secondary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). Adverse events were considered reportable if the event was related to the implant procedure, implanted pulse generator, or implanted leads.
5-years
Siello S Lead Effectiveness at 5 Years
Time Frame: 5-years
Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.
5-years
Pacing Threshold Measurements for Siello S Leads Through 5 Years
Time Frame: 5-years
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.
5-years
Sensing Measurements for Siello S Leads Through 5 Years
Time Frame: 5-years
Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
5-years
Impedance Measurements for Siello S Leads Through 5 Years
Time Frame: 5-years
Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G110221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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