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

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

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

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

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

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

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)

September 27, 2014

Primary Completion (Actual)

April 17, 2019

Study Completion (Actual)

April 17, 2019

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 18, 2014

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID 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.

Clinical Trials on Implantable Defibrillator User

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe