Protego DF4 Post Approval Registry

June 8, 2020 updated by: Biotronik, Inc.
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular 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.

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.
1694

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

  • 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

Exclusion Criteria:

  • 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

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

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
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.
Up to 4.5 years
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'.
Up to 4.5 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
Protego DF4 Lead Pacing Threshold Measurement
Time Frame: Up to 4.5 years
Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 years
Protego DF4 Lead Shock Impedance
Time Frame: Up to 4.5 years
Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 years
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
Time Frame: Up to 4.5 years
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).
Up to 4.5 years
Protego DF4 Lead Sensing
Time Frame: Up to 4.5 years
Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 years
Protego DF4 Lead Pacing Impedance
Time Frame: Up to 4.5 years
Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 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.
September 27, 2014

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).
September 11, 2014

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.
September 16, 2014

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.
September 18, 2014

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 22, 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.
June 8, 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.
June 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.
  • P980023/S057

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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