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TerminatedNCT02243696Updated Jun 22, 2020Results posted

Protego DF4 Post Approval Registry

An observational study in Implantable Defibrillator User, sponsored by Biotronik, Inc.. Terminated at 68 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-22.

Sponsored by Biotronik, Inc. · Observational

Why this study was terminated
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.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,694
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.

02

Conditions studied

  • Implantable Defibrillator User
03

In context

Lead sponsor

Biotronik, Inc. is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,694 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 4.5 years

  2. 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'.

    Time frame: Up to 4.5 years

Secondary outcomes

  1. 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.

    Time frame: Up to 4.5 years

  2. Protego DF4 Lead Shock Impedance

    Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.

    Time frame: Up to 4.5 years

  3. 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).

    Time frame: Up to 4.5 years

  4. Protego DF4 Lead Sensing

    Sensing measurements for the Protego DF4 leads through 5 years of follow-up.

    Time frame: Up to 4.5 years

  5. Protego DF4 Lead Pacing Impedance

    Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.

    Time frame: Up to 4.5 years

07

Results

Posted Apr 22, 2020

Participant flow

Participant flow — Overall Study
MilestoneBIOTRONIK Protego DF4 Lead
Started1694
Completed0
Not completed1694
Withdrew: Death282
Withdrew: Withdrawal by subject79
Withdrew: Lost to follow-up57
Withdrew: Subject no longer has study system42
Withdrew: Subject withdrawn by investigator273
Withdrew: Study terminated for ep passion961

Outcome measures

PrimaryPercentage 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.

Time frame:
Up to 4.5 years
Reported as:
Number · percentage of participants
Percentage of Subjects With No Protego DF4 Lead Adverse Event
percentage of participantsBIOTRONIK Protego DF4 Lead
Percentage of Subjects With No Protego DF4 Lead Adverse Event98.7 (98.04 to 99.18)
PrimaryProtego 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'.

Time frame:
Up to 4.5 years
Reported as:
Number · percentage of participants
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
percentage of participantsBIOTRONIK Protego DF4 Lead
Lead oversensing0.41 (0.17 to 0.85)
Lead conductor fracture0.30 (0.10 to 0.69)
Lead dislodgement0.18 (0.03 to 0.55)
Lead impedance our of range, high0.12 (0.01 to 0.43)
Lead impedance out of range, low0.12 (0.01 to 0.43)
Cardiac perforation0.06 (0.01 to 0.33)
Inability to extend helix0.06 (0.01 to 0.33)
Lead failure0.06 (0.01 to 0.33)
SecondaryProtego 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.

Time frame:
Up to 4.5 years
Reported as:
Mean · volts
Protego DF4 Lead Pacing Threshold Measurement
voltsBIOTRONIK Protego DF4 Lead
Protego DF4 Lead Pacing Threshold Measurement0.67 ± 0.36
SecondaryProtego DF4 Lead Shock Impedance

Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.

Time frame:
Up to 4.5 years
Reported as:
Mean · Ohms
Protego DF4 Lead Shock Impedance
OhmsBIOTRONIK Protego DF4 Lead
Protego DF4 Lead Shock Impedance71.5 ± 13.4
SecondaryPercentage 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).

Time frame:
Up to 4.5 years
Reported as:
Number · percentage of participants
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
percentage of participantsBIOTRONIK Protego DF4 Lead
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives90.73 (89.25 to 92.07)
SecondaryProtego DF4 Lead Sensing

Sensing measurements for the Protego DF4 leads through 5 years of follow-up.

Time frame:
Up to 4.5 years
Reported as:
Mean · millivolts
Protego DF4 Lead Sensing
millivoltsBIOTRONIK Protego DF4 Lead
Protego DF4 Lead Sensing15.70 ± 5.97
SecondaryProtego DF4 Lead Pacing Impedance

Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.

Time frame:
Up to 4.5 years
Reported as:
Mean · Ohms
Protego DF4 Lead Pacing Impedance
OhmsBIOTRONIK Protego DF4 Lead
Protego DF4 Lead Pacing Impedance552.3 ± 121.5

Adverse events

Collected over Up to 4.5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BIOTRONIK Protego DF4 Lead282/1,694 (16.6%)145/1,694 (8.6%)144/1,694 (8.5%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventBIOTRONIK Protego DF4 Lead
RV lead dislodgementCardiac disorders26/1694
Atrial lead dislodgementCardiac disorders21/1694
Primary infectionInfections and infestations21/1694
RV lead oversensing not due to external noiseCardiac disorders9/1694
HematomaSurgical and medical procedures9/1694
Secondary infectionInfections and infestations7/1694
LV lead dislodgementCardiac disorders6/1694
RV lead conductor fractureCardiac disorders6/1694
LV lead diaphragmatic stimulationCardiac disorders5/1694
RV lead high pacing thresholdCardiac disorders5/1694
Most frequent other events
Showing 10 of 32
Most frequent other events
EventBIOTRONIK Protego DF4 Lead
LV lead high pacing thresholdCardiac disorders59/1694
LV lead diaphragmatic stimulationCardiac disorders31/1694
Atrial lead high pacing thresholdCardiac disorders13/1694
RV lead high pacing thresholdCardiac disorders10/1694
Atrial lead dislodgementCardiac disorders5/1694
LV lead intermittent capture / no lead captureCardiac disorders5/1694
Pulse generator back-up mode initiatedCardiac disorders5/1694
Atrial lead impedance out of range, high impedanceCardiac disorders3/1694
Inability to extend helix during implant procedureCardiac disorders3/1694
RV lead oversensing not due to external noiseCardiac disorders3/1694

Baseline characteristics

Age, Continuous
Age, Continuous(years)BIOTRONIK Protego DF4 Lead
Mean65.5 ± 12.49
Sex: Female, Male
Sex: Female, Male(Participants)BIOTRONIK Protego DF4 Lead
Female481
Male1213
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BIOTRONIK Protego DF4 Lead
Hispanic or Latino177
Not Hispanic or Latino1326
Unknown or Not Reported191
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BIOTRONIK Protego DF4 Lead
American Indian or Alaska Native7
Asian31
Native Hawaiian or Other Pacific Islander5
Black or African American340
White1130
More than one race0
Unknown or Not Reported181
Weight
Weight(pounds)BIOTRONIK Protego DF4 Lead
Mean196.3 ± 51.28
Height
Height(inches)BIOTRONIK Protego DF4 Lead
Mean67.7 ± 4.11
08

Study locations

68 sites
  • Gadsden, Alabama, United States
  • Avondale, Arizona, United States
  • Glendale, Arizona, United States
  • Peoria, Arizona, United States
  • Phoenix, Arizona, United States
  • 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
  • Norwalk, Connecticut, United States
  • 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
  • Alton, Illinois, United States
  • Aurora, Illinois, United States
  • Chicago, Illinois, United States
  • Schaumburg, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Lexington, Kentucky, United States
  • Owensboro, Kentucky, United States
  • Lafayette, Louisiana, United States
  • Lake Charles, Louisiana, United States
  • Bangor, Maine, United States
  • Baltimore, Maryland, United States
  • Cumberland, Maryland, United States
  • Worcester, Massachusetts, United States
  • 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
  • Saint Louis, Missouri, United States
  • Clifton, New Jersey, United States
  • Mineola, New York, United States
  • Stony Brook, New York, United States
  • Winston-Salem, North Carolina, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • Middletown, Ohio, United States
  • Steubenville, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • 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
  • 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
  • Burlington, Vermont, United States
  • Chesapeake, Virginia, United States
  • Fredericksburg, Virginia, United States
  • Norfolk, Virginia, United States
  • Seattle, Washington, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 14, 2014

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02243696
Lead sponsor
Biotronik, Inc.
Responsible party
Sponsor
First posted
Sep 18, 2014
Start date
Sep 27, 2014
Primary completion
Apr 17, 2019
Completion
Apr 17, 2019
Results posted
Apr 22, 2020
Last update
Jun 22, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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