Implantable Defibrillator UserNCT02243696

Protego DF4 Post Approval Registry

An observational study of Implantable Defibrillator User, run by Biotronik, Inc. at 68 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 study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular 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: 1,694 participants
Where: 68 sitesUnited States
Study dates: 27 Sep 2014to 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

Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead
Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies
Able to understand the nature of the registry 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 investigational cardiac device trial
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
Presence of another life-threatening, underlying illness separate from their cardiac disorder
Patients reporting pregnancy at the time of enrollment

Trial locations and contacts

68 sites in 1 country.

City, postcode or hospital

68 sites in 1 country

United States68 sites

Study site
Alton, Illinois
Study site
Anderson, South Carolina
Study site
Aurora, Illinois
Study site
Avondale, Arizona
Study site
Baltimore, Maryland
Study site
Bangor, Maine
Study site
Brooksville, Florida
Study site
Burlington, Vermont
Study site
Chesapeake, Virginia
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clifton, New Jersey
Study site
Columbia, South Carolina
Study site
Corpus Christi, Texas
Study site
Cumberland, Maryland
Study site
Daytona Beach, Florida
Study site
Detroit, Michigan
Study site
Escondido, California
Study site
Fargo, North Dakota
Study site
Flint, Michigan
Study site
Fort Wayne, Indiana
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Fredericksburg, Virginia
Study site
Gadsden, Alabama
Study site
Glendale, Arizona
Study site
Greenville, South Carolina
Study site
Hawthorne, California
Study site
Houston, Texas
Study site
Kingwood, Texas
Study site
Kissimmee, Florida
Study site
Lafayette, Louisiana
Study site
Lake Charles, Louisiana
Study site
Lancaster, South Carolina
Study site
Lansing, Michigan
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Middletown, Ohio
Study site
Mineola, New York
Study site
Mt. Pleasant, South Carolina
Study site
New Smyrna Beach, Florida
Study site
Norfolk, Virginia
Study site
Norwalk, Connecticut
Study site
Orlando, Florida
Study site
Owensboro, Kentucky
Study site
Peoria, Arizona
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Rochester Hills, Michigan
Study site
Rock Hill, South Carolina
Study site
San Antonio, Texas
Study site
Santa Barbara, California
Study site
Schaumburg, Illinois
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Steubenville, Ohio
Study site
Stony Brook, New York
Study site
Temecula, California
Study site
Tomball, Texas
Study site
Torrance, California
Study site
Winston-Salem, North Carolina
Study site
Winter Park, Florida
Study site
Worcester, Massachusetts
Study site
Wyoming, Michigan
Study site
Ypsilanti, Michigan
Study site
Zephyrhills, Florida

Other trials in United States

About this study

The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular 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 With No Protego DF4 Lead Adverse Event
Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Measured: Up to 4.5 years
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.
Measured: Up to 4.5 years

Secondary outcomes (5)

Protego DF4 Lead Pacing Threshold Measurement
Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
Measured: Up to 4.5 years
Protego DF4 Lead Shock Impedance
Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Measured: Up to 4.5 years
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).
Measured: Up to 4.5 years
Protego DF4 Lead Sensing
Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
Measured: Up to 4.5 years
Protego DF4 Lead Pacing Impedance
Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Measured: Up to 4.5 years

Timeline

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

27 Sep 201417 Apr 2019

First posted18 Sep 2014 (estimated)
Study start27 Sep 2014
Primary completion17 Apr 2019
Study completion17 Apr 2019

Why it stopped: On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing Protego DF4 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.
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: 1,694 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02243696
Sponsor's protocol ID: P980023/S057
Status last verified: Jun 2020
First submitted: 11 Sep 2014
Last updated: 22 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

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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 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protego DF4 Post Approval Registry
ClinicalTrials.gov ID: NCT02243696
Acronym / sponsor ID: P980023/S057
Conditions: Implantable Defibrillator User
Study type: Observational
Recruitment status: TerminatedReason stopped: On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing Protego DF4 Post Approval Registry to a new EP PASSION real-world data methodology.
Enrolment: 1,694 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: 27 Sep 2014 (actual)
Primary completion: 17 Apr 2019 (actual)
Study completion: 17 Apr 2019 (actual)
First posted: 18 Sep 2014 (estimated)
Results: Posted 22 Apr 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 study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular 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 patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Key inclusion criteria (5 listed)

Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead
Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies
Able to understand the nature of the registry 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 (6 listed)

Enrolled in any investigational cardiac device trial
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
Presence of another life-threatening, underlying illness separate from their cardiac disorder

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 With No Protego DF4 Lead Adverse Event
Time frame: Up to 4.5 years
Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Time frame: Up to 4.5 years
Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.

5 secondary outcomes

Protego DF4 Lead Pacing Threshold Measurement
Time frame: Up to 4.5 years
Protego DF4 Lead Shock Impedance
Time frame: Up to 4.5 years
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
Time frame: Up to 4.5 years
Protego DF4 Lead Sensing
Time frame: Up to 4.5 years
Protego DF4 Lead Pacing Impedance
Time frame: Up to 4.5 years

Results and safety

Results posted to the registry on 22 Apr 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 Protego DF4 Lead	1,694	0

Primary outcome: Percentage of Subjects With No Protego DF4 Lead Adverse Event

Time frame: Up to 4.5 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	BIOTRONIK Protego DF4 Lead n = 1694
Value	98.7 (98.04 to 99.18)

Primary outcome: Protego DF4 Lead Safety-Individual Adverse Event-Free Rate

Time frame: Up to 4.5 years. Number (95% Confidence Interval). Unit: percentage of participants

Measure	BIOTRONIK Protego DF4 Lead n = 1694
Lead oversensing	0.41 (0.17 to 0.85)
Lead conductor fracture	0.30 (0.10 to 0.69)
Lead dislodgement	0.18 (0.03 to 0.55)
Lead impedance our of range, high	0.12 (0.01 to 0.43)
Lead impedance out of range, low	0.12 (0.01 to 0.43)
Cardiac perforation	0.06 (0.01 to 0.33)
Inability to extend helix	0.06 (0.01 to 0.33)
Lead failure	0.06 (0.01 to 0.33)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4.5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIOTRONIK Protego DF4 Lead	145 of 1,694 (8.6%)	144 of 1,694 (8.5%)	282 of 1,694

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

68 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 68 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 22 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 68 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 22 Apr 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 With No Protego DF4 Lead Adverse Event (time frame: Up to 4.5 years). The study lists 2 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 NCT02243696.

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 22 Jun 2020.