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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.
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The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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'. | Up to 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4.5 years |
| Protego DF4 Lead Shock Impedance |
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Inclusion Criteria:
Exclusion Criteria:
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The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gadsden | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | BIOTRONIK Protego DF4 Lead | Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2014 |
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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 | 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 | Sensing measurements for the Protego DF4 leads through 5 years of follow-up. | Up to 4.5 years |
| Protego DF4 Lead Pacing Impedance | Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up. | Up to 4.5 years |
| 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 |
| St. 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 |
| St 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 |
| Mt. 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 |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BIOTRONIK Protego DF4 Lead | Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Weight | Baseline characteristics are provided when available, subjects without an available baseline characteristic are not included in the number of participants analyzed for that characteristic. | Mean | Standard Deviation | pounds |
| ||||||||||||||||
| Height | Baseline characteristics are provided when available, subjects without an available baseline characteristic are not included in the number of participants analyzed for that characteristic. | Mean | Standard Deviation | inches |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 4.5 years |
|
|
| ||||||||||||||||||||||||||
| Primary | 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'. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 4.5 years |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | A threshold measurement for the Protego lead using a pulse width of 0.4 or 0.5 ms was unavailable for one subject. This patient was excluded from the analysis of this outcome measure. | Posted | Mean | Standard Deviation | volts | Up to 4.5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Protego DF4 Lead Shock Impedance | Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up. | Posted | Mean | Standard Deviation | Ohms | Up to 4.5 years |
|
| |||||||||||||||||||||||||||
| Secondary | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 4.5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Protego DF4 Lead Sensing | Sensing measurements for the Protego DF4 leads through 5 years of follow-up. | Posted | Mean | Standard Deviation | millivolts | Up to 4.5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Protego DF4 Lead Pacing Impedance | Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up. | Posted | Mean | Standard Deviation | Ohms | Up to 4.5 years |
|
|
Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected.
Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIOTRONIK Protego DF4 Lead | Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header. | 282 | 1,694 | 145 | 1,694 | 144 | 1,694 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial lead conductor fracture | Cardiac disorders | Systematic Assessment |
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| Atrial lead dislodgement | Cardiac disorders | Systematic Assessment |
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| Atrial lead high pacing threshold | Cardiac disorders | Systematic Assessment |
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| Cardiac perforation | Cardiac disorders | Systematic Assessment |
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| Inability to defibrillate successfully with the Protego lead | Cardiac disorders | Systematic Assessment |
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| LV lead diaphragmatic stimulation | Cardiac disorders | Systematic Assessment |
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| LV lead dislodgement | Cardiac disorders | Systematic Assessment |
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| LV lead high pacing threshold | Cardiac disorders | Systematic Assessment |
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| LV lead impedance out of range, high impedance | Cardiac disorders | Systematic Assessment |
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| LV lead intermittent capture / no lead capture | Cardiac disorders | Systematic Assessment |
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| Premature battery depletion | Cardiac disorders | Systematic Assessment |
| ||
| Pulse generator failure | Cardiac disorders | Systematic Assessment |
| ||
| Pulse generator migration | Cardiac disorders | Systematic Assessment |
| ||
| RV lead conductor fracture | Cardiac disorders | Systematic Assessment |
| ||
| RV lead dislodgement | Cardiac disorders | Systematic Assessment |
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| RV lead failure | Cardiac disorders | Systematic Assessment |
| ||
| RV lead high pacing threshold | Cardiac disorders | Systematic Assessment |
| ||
| RV lead impedance out of range, high impedance | Cardiac disorders | Systematic Assessment |
| ||
| RV lead impedance out of range, low impedance | Cardiac disorders | Systematic Assessment |
| ||
| RV lead intermittent capture / no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| RV lead oversensing not due to external noise | Cardiac disorders | Systematic Assessment |
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| RV lead undersensing or loss of sensing | Cardiac disorders | Systematic Assessment |
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| Pulmonary embolism | General disorders | Systematic Assessment |
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| Twiddler's syndrome | General disorders | Systematic Assessment |
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| Primary infection | Infections and infestations | Systematic Assessment |
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| Secondary infection | Infections and infestations | Systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cardiac perforation with or without tamponade | Surgical and medical procedures | Systematic Assessment |
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| Coronary sinus dissection | Surgical and medical procedures | Systematic Assessment |
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| Hematoma | Surgical and medical procedures | Systematic Assessment |
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| Loose set-screw | Surgical and medical procedures | Systematic Assessment |
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| Pneumothorax | Surgical and medical procedures | Systematic Assessment |
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| Pocket pain | Surgical and medical procedures | Systematic Assessment |
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| Pulmonary embolism | Surgical and medical procedures | Systematic Assessment |
| ||
| Venous occlusion | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| Atrial lead high pacing threshold | Cardiac disorders | Systematic Assessment |
| ||
| Atrial lead impedance out of range, high impedance | Cardiac disorders | Systematic Assessment |
| ||
| Atrial lead impedance out of range, low impedance | Cardiac disorders | Systematic Assessment |
| ||
| Atrial lead intermittent capture / no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| Bent connector pin noted during implant procedure | Cardiac disorders | Systematic Assessment |
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| Inability to extend helix during implant procedure | Cardiac disorders | Systematic Assessment |
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| Inability to successfully implant Protego lead | Cardiac disorders | Systematic Assessment |
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| LV lead diaphragmatic stimulation | Cardiac disorders | Systematic Assessment |
| ||
| LV lead dislodgement | Cardiac disorders | Systematic Assessment |
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| LV lead high pacing threshold | Cardiac disorders | Systematic Assessment |
| ||
| LV lead impedance out of range, high impedance | Cardiac disorders | Systematic Assessment |
| ||
| LV lead intermittent capture / no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| LV lead oversensing not due to external noise | Cardiac disorders | Systematic Assessment |
| ||
| Pulse generator back-up mode initiated | Cardiac disorders | Systematic Assessment |
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| RV lead diaphragmatic stimulation | Cardiac disorders | Systematic Assessment |
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| RV lead high pacing threshold | Cardiac disorders | Systematic Assessment |
| ||
| RV lead impedance out of range, high impedance | Cardiac disorders | Systematic Assessment |
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| RV lead impedance out of range, low impedance | Cardiac disorders | Systematic Assessment |
| ||
| RV lead intermittent capture / no lead capture | Cardiac disorders | Systematic Assessment |
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| RV lead oversensing not due to external noise | Cardiac disorders | Systematic Assessment |
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| RV lead undersensing or loss of sensing | Cardiac disorders | Systematic Assessment |
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| Lightheadedness | General disorders | Systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Damage to lead during procedure (e.g. accidental cut to lead body during pocket revision, device rep | Surgical and medical procedures | Systematic Assessment |
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| Hematoma | Surgical and medical procedures | Systematic Assessment |
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| Inability to successfully implant Protego lead due to patient anatomy | Surgical and medical procedures | Systematic Assessment |
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| Pocket pain | Surgical and medical procedures | Systematic Assessment |
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| RA lead dislodgement during a procedure | Surgical and medical procedures | Systematic Assessment |
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| RV lead dislodgement during a procedure | Surgical and medical procedures | Systematic Assessment |
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| Venous occlusion | Surgical and medical procedures | Systematic Assessment |
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| Venous thrombosis without pulmonary embolism | Surgical and medical procedures | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Engineer Manager | BIOTRONIK, Inc. | 1-800-547-0394 | crystal.miller@biotronik.com |
| Dec 16, 2019 |
| Prot_SAP_000.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Lead oversensing |
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| Lead conductor fracture |
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| Lead dislodgement |
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| Lead impedance our of range, high |
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| Lead impedance out of range, low |
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| Cardiac perforation |
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| Inability to extend helix |
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| Lead failure |
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