Implantable Defibrillator UserNCT03103503

Plexa ICD Lead Registry

An observational study of Implantable Defibrillator User, run by Biotronik, Inc. at 28 sites in United States.

Terminated

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

Trial summary

The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Implantable Defibrillator User
How many people: 901 participants
Where: 28 sitesUnited States
Study dates: 18 May 2017to 27 Sep 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 subject selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

Who may be able to join

Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent
Able to understand the nature of the registry and provide informed consent
Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
Accepts BIOTRONIK Home Monitoring® concept
Age greater than or equal to 18 years

Who cannot join

Enrolled in any investigational cardiac device trial
Enrolled in BIOTRONIK's QP ExCELs lead study
Planned cardiac surgical procedures or interventional measures within the next 6 months
Expected to receive heart transplantation or ventricular assist device within 1 year
Life expectancy of less than 1 year
Patients reporting pregnancy at the time of enrollment

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

St. Louis Cardiology Consultants
Alton, Illinois, 62002
University of Michigan
Ann Arbor, Michigan, 48109
Northern Light Cardiology
Bangor, Maine, 04401
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
The Ohio State Wexner Medical Center
Columbus, Ohio, 43210
Thomas Hospital Research Office
Fairhope, Alabama, 36532
Sanford Medical Center
Fargo, North Dakota, 58102
Upstate Cardiology
Greenville, South Carolina, 29607
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Glacier View Research Institute Cardiology
Kalispell, Montana, 59901
Carolina Heart Specialists
Lancaster, South Carolina, 29720
Jeffrey S Goodman MD
Los Angeles, California, 90048
The Arrhythmia Institute
Newtown, Pennsylvania, 18940
Florida Hospital
Orlando, Florida, 32803
Research Integrity LLC
Owensboro, Kentucky, 42303
Eisenhower Desert Cardiology
Rancho Mirage, California, 92270
Carolina Cardiology Associates
Rock Hill, South Carolina, 29732
Mercy Clinic Cardiology
Springfield, Missouri, 65804
St. Louis Heart and Vascular
St Louis, Missouri, 63122
Gateway Cardiovascular Research Center
St Louis, Missouri, 63128
Mercy Clinic Heart and Vascular
St Louis, Missouri, 63141
Advent Health Tampa
Tampa, Florida, 33613
Toledo Cardiology
Toledo, Ohio, 43608
Cardiovascular Associates Ltd
Virginia Beach, Virginia, 23454
Heartland Cardiology
Wichita, Kansas, 67205
Novant Health
Winston-Salem, North Carolina, 27103
Metro Health Hospital
Wyoming, Michigan, 49519
Michigan Heart
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.

Conditions: Implantable Defibrillator User

What is being measured

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

Percentage of Subjects Free From Plexa Lead Related Adverse Events
Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.
Measured: Up to 2.5 years

Secondary outcomes (6)

Plexa Lead Safety-Individual Adverse Events
Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'
Measured: Up to 2.5 years
Pacing Threshold Measurements for the Plexa Lead Through Study Termination
Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.
Measured: Up to 2.5 years
Sensing Measurements for the Plexa Lead Through Study Termination
Sensing measurements for the Plexa leads at completed follow-up visits.
Measured: Up to 2.5 years
Pacing Impedance Measurements for the Plexa Lead Through Study Termination
Pacing impedance measurements for the Plexa leads at completed follow-up visits.
Measured: Up to 2.5 years
Shock Impedance for the Plexa Lead Through Study Termination
Shock impedance measurements for the Plexa leads at completed follow-up visits.
Measured: Up to 2.5 years
Percentage of Subjects Free From Protocol Defined Adverse Events
Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate.
Measured: Up to 2.5 years

Timeline

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

18 May 201727 Sep 2019

First posted6 Apr 2017
Study start18 May 2017
Primary completion27 Sep 2019
Study completion27 Sep 2019

Why it stopped: Collection of long term lead performance is being transferred to an alternate data collection 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.
Other trials for Implantable Defibrillator UserStudies 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: 901 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03103503
Sponsor's protocol ID: Plexa Registry
Status last verified: Sep 2020
First submitted: 31 Mar 2017
Last updated: 14 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Enrolling by invitationObservational study
TRAjectories and CLinical ExpeRiences of ICD Therapy Study
Implantable Defibrillator User
Recruiting
Effectiveness of Exercise After an ICD
Heart Arrest, Implantable Defibrillator User
Recruiting
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Pacemaker DDD, Implantable Defibrillator User
Recruiting
Self-Management Interventions After an ICD Shock
Implantable Defibrillator User, Stress Reaction

All Implantable Defibrillator User trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Plexa ICD Lead Registry
ClinicalTrials.gov ID: NCT03103503
Acronym / sponsor ID: Plexa Registry
Conditions: Implantable Defibrillator User
Study type: Observational
Recruitment status: TerminatedReason stopped: Collection of long term lead performance is being transferred to an alternate data collection methodology.
Enrolment: 901 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: 18 May 2017 (actual)
Primary completion: 27 Sep 2019 (actual)
Study completion: 27 Sep 2019 (actual)
First posted: 6 Apr 2017 (actual)
Results: Posted 14 Oct 2020

Clinical summary

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

The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 5 Years

Who may qualify

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

Key inclusion criteria (5 listed)

Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent
Able to understand the nature of the registry and provide informed consent
Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up
Accepts BIOTRONIK Home Monitoring® concept
Age greater than or equal to 18 years

Key exclusion criteria (6 listed)

Enrolled in any investigational cardiac device trial
Enrolled in BIOTRONIK's QP ExCELs lead study
Planned cardiac surgical procedures or interventional measures within the next 6 months
Expected to receive heart transplantation or ventricular assist device within 1 year
Life expectancy of 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.

Primary outcome

Percentage of Subjects Free From Plexa Lead Related Adverse Events
Time frame: Up to 2.5 years
Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.

6 secondary outcomes

Plexa Lead Safety-Individual Adverse Events
Time frame: Up to 2.5 years
Pacing Threshold Measurements for the Plexa Lead Through Study Termination
Time frame: Up to 2.5 years
Sensing Measurements for the Plexa Lead Through Study Termination
Time frame: Up to 2.5 years
Pacing Impedance Measurements for the Plexa Lead Through Study Termination
Time frame: Up to 2.5 years
Shock Impedance for the Plexa Lead Through Study Termination
Time frame: Up to 2.5 years
Percentage of Subjects Free From Protocol Defined Adverse Events
Time frame: Up to 2.5 years

Results and safety

Results posted to the registry on 14 Oct 2020, 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 Plexa ICD Lead	901	0

Primary outcome: Percentage of Subjects Free From Plexa Lead Related Adverse Events

Time frame: Up to 2.5 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	BIOTRONIK Plexa ICD Lead n = 901
Value	100.00 (99.49 to 100.00)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Though study exit or study termination, an average of 1.1 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIOTRONIK Plexa ICD Lead	44 of 901 (4.9%)	12 of 901 (1.3%)	64 of 901

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Implantable Defibrillator User

Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Enrolling by invitationObservational study
TRAjectories and CLinical ExpeRiences of ICD Therapy Study
Implantable Defibrillator User
Recruiting
Effectiveness of Exercise After an ICD
Heart Arrest, Implantable Defibrillator User
Recruiting
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Pacemaker DDD, Implantable Defibrillator User
Recruiting
Self-Management Interventions After an ICD Shock
Implantable Defibrillator User, Stress Reaction

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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Implantable Defibrillator User, run by Biotronik, Inc. at 28 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 5 inclusion and 6 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 14 Oct 2020). 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?

Percentage of Subjects Free From Plexa Lead Related Adverse Events (time frame: Up to 2.5 years). 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 NCT03103503.

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 14 Oct 2020.