Safety and Effectiveness of the Siello S LeadSIELLONCT01791127

Safety and Performance Study of the Siello S Pacing Lead

An observational study of Safety and Effectiveness of the Siello S Lead, run by Biotronik, Inc. at 53 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Safety and Effectiveness of the Siello S Lead
What is being tested?: market-released BIOTRONIK pacemaker system including one or two Siello S leads.
Type of treatment: Medical device
How many people: 1,758 participants
Where: 53 sitesUnited States
Study dates: 13 Mar 2013to 17 Apr 2019
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Who may be able to join

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.

Who cannot join

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 locations and contacts

53 sites in 1 country.

City, postcode or hospital

53 sites in 1 country

United States53 sites

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

Other trials in United States

About this study

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

Conditions: Safety and Effectiveness of the Siello S Lead
Being tested: market-released BIOTRONIK pacemaker system including one or two Siello S leads.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01791127
Study group	Role	What they receive
Pacemaker Therapy		Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads. Receives: Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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'.
Measured: 5-years

Secondary outcomes (10)

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).
Measured: 5-years
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.
Measured: 5-years
Pacing Threshold Measurements for Siello S Leads at 12 Months
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Measured: 12-months
Sensing Measurements for Siello S Leads at 12 Months
Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Measured: 12-months
Impedance Measurements for Siello S Leads at 12 Months
Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Measured: 12-months
Percentage of Participants With Other Adverse Events
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.
Measured: 5-years
Siello S Lead Effectiveness at 5 Years
Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.
Measured: 5-years
Pacing Threshold Measurements for Siello S Leads Through 5 Years
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.
Measured: 5-years
Sensing Measurements for Siello S Leads Through 5 Years
Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
Measured: 5-years
Impedance Measurements for Siello S Leads Through 5 Years
Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
Measured: 5-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201317 Apr 2019

First posted13 Feb 2013 (estimated)
Study start13 Mar 2013
Primary completion17 Apr 2019
Study completion17 Apr 2019

Why it stopped: On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Safety and Effectiveness of the Siello S LeadStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,758 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT01791127
Sponsor's protocol ID: G110221
Acronym: SIELLO
Status last verified: May 2020
First submitted: 12 Feb 2013
Last updated: 1 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Mullane S, Hicks JB, Sharmin K, Harrell C, Rock A, Miller C. Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data. Pragmat Obs Res. 2024 Dec 19;15:233-241. doi: 10.2147/POR.S499248. eCollection 2024.
PubMed 39720009

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Performance Study of the Siello S Pacing Lead
ClinicalTrials.gov ID: NCT01791127
Acronym / sponsor ID: SIELLO / G110221
Conditions: Safety and Effectiveness of the Siello S Lead
Study type: Observational
Recruitment status: TerminatedReason stopped: On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology.
Enrolment: 1,758 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: 13 Mar 2013 (actual)
Primary completion: 17 Apr 2019 (actual)
Study completion: 17 Apr 2019 (actual)
First posted: 13 Feb 2013 (estimated)
Results: Posted 31 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 1

Arm	Type	Receives
Pacemaker Therapy	–	Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
market-released BIOTRONIK pacemaker system including one or two Siello S leads.	Device	Pacemaker Therapy

Primary outcome

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).
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).
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.
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).
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'.

10 secondary outcomes

Atrial Siello S Lead Safety at 5 Years
Time frame: 5-years
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Time frame: 5-years
Pacing Threshold Measurements for Siello S Leads at 12 Months
Time frame: 12-months
Sensing Measurements for Siello S Leads at 12 Months
Time frame: 12-months
Impedance Measurements for Siello S Leads at 12 Months
Time frame: 12-months
Percentage of Participants With Other Adverse Events
Time frame: 5-years
Siello S Lead Effectiveness at 5 Years
Time frame: 5-years
Pacing Threshold Measurements for Siello S Leads Through 5 Years
Time frame: 5-years
Sensing Measurements for Siello S Leads Through 5 Years
Time frame: 5-years
Impedance Measurements for Siello S Leads Through 5 Years
Time frame: 5-years

Results and safety

Results posted to the registry on 31 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIOTRONIK Siello S Lead	1,758	286

Primary outcome: Atrial Siello S Lead Safety at 12 Months

Time frame: 12 month. Number (95% Confidence Interval). Unit: percentage of participants

Measure	BIOTRONIK Siello S Atrial Lead n = 450
Value	100 (99.2 to 100)

BIOTRONIK Siello S Atrial Lead: p <0.0001, Exact, binomial

Population analysed: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of an atrial Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.

Primary outcome: Ventricular Siello S Lead Safety at 12 Months

Time frame: 12-month. Number (95% Confidence Interval). Unit: percentage of participants

Measure	BIOTRONIK Siello S Ventricular Lead n = 525
Value	99.62 (98.6 to 100)

BIOTRONIK Siello S Ventricular Lead: p <0.0001, Exact, binomial

Population analysed: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of a ventricular Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.

Primary outcome: Siello S Lead Effectiveness at 12 Months

Time frame: 12-months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	BIOTRONIK Siello S Lead n = 538
Value	100 (99.3 to 100)

BIOTRONIK Siello S Lead: p <0.0001, Exact, binomial

Population analysed: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of one or more Siello leads on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.

Primary outcome: Ventricular Siello S Lead Safety at 5 Years

Time frame: 5-Years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	BIOTRONIK Siello S Ventricular Lead n = 1728
Value	99.71 (99.33 to 99.91)

Population analysed: The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right ventricular position.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIOTRONIK Siello S Lead	145 of 1,758 (8.2%)	154 of 1,758 (8.8%)	356 of 1,758

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39720009Mullane S, Hicks JB, Sharmin K, Harrell C, Rock A, Miller C. Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data. Pragmat Obs Res. 2024 Dec 19;15:233-241. doi: 10.2147/POR.S499248. eCollection 2024.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

53 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Safety and Effectiveness of the Siello S Lead, run by Biotronik, Inc. at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial Siello S Lead Safety at 12 Months (time frame: 12 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01791127, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.