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Collection of long term lead performance is being transferred to an alternate data collection methodology.
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The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Free From Plexa Lead Related Adverse Events | Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture. | Up to 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Plexa Lead Safety-Individual Adverse Events | Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events' | Up to 2.5 years |
| Pacing Threshold Measurements for the Plexa Lead Through Study Termination |
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Inclusion Criteria:
Exclusion Criteria:
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The subject selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Hospital Research Office | Fairhope | Alabama | 36532 | United States | ||
| Jeffrey S Goodman MD |
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| ID | Title | Description |
|---|---|---|
| FG000 | BIOTRONIK Plexa ICD Lead | Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead. |
| 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 | Mar 1, 2017 |
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Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits. |
| Up to 2.5 years |
| Sensing Measurements for the Plexa Lead Through Study Termination | Sensing measurements for the Plexa leads at completed follow-up visits. | Up to 2.5 years |
| Pacing Impedance Measurements for the Plexa Lead Through Study Termination | Pacing impedance measurements for the Plexa leads at completed follow-up visits. | Up to 2.5 years |
| Shock Impedance for the Plexa Lead Through Study Termination | Shock impedance measurements for the Plexa leads at completed follow-up visits. | Up to 2.5 years |
| Percentage of Subjects Free From Protocol Defined Adverse Events | Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate. | Up to 2.5 years |
| Los Angeles |
| California |
| 90048 |
| United States |
| Eisenhower Desert Cardiology | Rancho Mirage | California | 92270 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Advent Health Tampa | Tampa | Florida | 33613 | United States |
| St. Louis Cardiology Consultants | Alton | Illinois | 62002 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Heartland Cardiology | Wichita | Kansas | 67205 | United States |
| Research Integrity LLC | Owensboro | Kentucky | 42303 | United States |
| Northern Light Cardiology | Bangor | Maine | 04401 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Mercy Clinic Cardiology | Springfield | Missouri | 65804 | United States |
| St. Louis Heart and Vascular | St Louis | Missouri | 63122 | United States |
| Gateway Cardiovascular Research Center | St Louis | Missouri | 63128 | United States |
| Mercy Clinic Heart and Vascular | St Louis | Missouri | 63141 | United States |
| Glacier View Research Institute Cardiology | Kalispell | Montana | 59901 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Novant Health | Winston-Salem | North Carolina | 27103 | United States |
| Sanford Medical Center | Fargo | North Dakota | 58102 | United States |
| The Ohio State Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Toledo Cardiology | Toledo | Ohio | 43608 | United States |
| The Arrhythmia Institute | Newtown | Pennsylvania | 18940 | United States |
| Upstate Cardiology | Greenville | South Carolina | 29607 | United States |
| Carolina Heart Specialists | Lancaster | South Carolina | 29720 | United States |
| Carolina Cardiology Associates | Rock Hill | South Carolina | 29732 | United States |
| Cardiovascular Associates Ltd | Virginia Beach | Virginia | 23454 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BIOTRONIK Plexa ICD Lead | Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data collected and analyzed when available, not all subjects had data available for this measurement. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Data collected and analyzed when available, not all subjects had data available for this measurement. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Height | Data collected and analyzed when available, not all subjects had data available for this measurement. | Mean | Standard Deviation | inches |
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| Weight | Data collected and analyzed when available, not all subjects had data available for this measurement. | Mean | Standard Deviation | pounds |
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| 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 Free From Plexa Lead Related Adverse Events | Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2.5 years |
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| Secondary | Plexa Lead Safety-Individual Adverse Events | Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events' | No primary outcome adverse events were reported; therefore, there are no individual events to be analyzed. | Posted | Up to 2.5 years |
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| Secondary | Pacing Threshold Measurements for the Plexa Lead Through Study Termination | Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits. | Posted | Mean | Standard Deviation | V | Up to 2.5 years | visits with measurement | visits with measurement |
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| Secondary | Sensing Measurements for the Plexa Lead Through Study Termination | Sensing measurements for the Plexa leads at completed follow-up visits. | Posted | Mean | Standard Deviation | mV | Up to 2.5 years | visits with measurement | visits with measurement |
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| Secondary | Pacing Impedance Measurements for the Plexa Lead Through Study Termination | Pacing impedance measurements for the Plexa leads at completed follow-up visits. | Posted | Mean | Standard Deviation | ohms | Up to 2.5 years | visits with measurement | visits with measurement |
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| Secondary | Shock Impedance for the Plexa Lead Through Study Termination | Shock impedance measurements for the Plexa leads at completed follow-up visits. | Posted | Mean | Standard Deviation | ohms | Up to 2.5 years | visits with measurement | visits with measurement |
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| Secondary | Percentage of Subjects Free From Protocol Defined Adverse Events | Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2.5 years |
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Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
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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 Plexa ICD Lead | Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead. | 64 | 901 | 44 | 901 | 12 | 901 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Loose set-screw | Surgical and medical procedures | Systematic Assessment |
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| Non-healing pocket dehiscence requiring intervention | Surgical and medical procedures | Systematic Assessment |
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| Cardiogenic shock during implantation | Surgical and medical procedures | Systematic Assessment |
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| Operation wound bleeding | Surgical and medical procedures | Systematic Assessment |
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| Venous occlusion associated with the implant procedure | Surgical and medical procedures | Systematic Assessment |
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| LV lead related high pacing threshold | Cardiac disorders | Systematic Assessment |
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| LV lead related lead dislodgement | Cardiac disorders | Systematic Assessment |
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| Twiddler's syndrome | General disorders | Systematic Assessment |
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| RV lead related lead dislodgement | Cardiac disorders | Systematic Assessment |
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| RV lead related other: high defibrillation threshold.no evidence for lead malfunction | Cardiac disorders | Systematic Assessment |
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| RA lead related lead dislodgement | Cardiac disorders | Systematic Assessment |
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| Pulmonary Emboli | General disorders | Systematic Assessment |
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| RV lead related high pacing threshold | Cardiac disorders | Systematic Assessment |
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| RV lead related intermittent capture | Cardiac disorders | Systematic Assessment |
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| RV lead related lead impedance out of range, high | Cardiac disorders | Systematic Assessment |
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| RV lead related lead undersensing | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | Systematic Assessment |
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| Non-healing pocket dehiscence requiring intervention | Surgical and medical procedures | Systematic Assessment |
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| Slow wound healing, no sign for infection | Surgical and medical procedures | Systematic Assessment |
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| Thrombosis | Surgical and medical procedures | Systematic Assessment |
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| LV lead related extracardiac stimulation | Cardiac disorders | Systematic Assessment |
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| LV lead related lead impedance out of range, high | Cardiac disorders | Systematic Assessment |
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| RV lead related lead dislodgement | Cardiac disorders | Systematic Assessment |
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| RV lead related other: positional atrial undersensing | Cardiac disorders | Systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| RA lead related lead dislodgement | Cardiac disorders | Systematic Assessment |
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| RA lead related no capture | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Engineer Manager | BIOTRONIK | 800-547-0394 | crystal.miller@biotronik.com |
| Jan 16, 2020 |
| Prot_SAP_000.pdf |
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