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The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
The primary endpoints of the study are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of a QuickFlex® μ Model 1258T LV Lead | Device | Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Alive and Without a Left Ventricular Lead-related Complication | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol). | 5 years |
| Left Ventricular Bipolar Pacing Capture Threshold | Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an approved indication for implantation of a CRT-D system
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| Name | Affiliation | Role |
|---|---|---|
| Clay Cohorn | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Associates P.C. | Birmingham | Alabama | 35213 | United States | ||
| University Hospital - Univ. of Alabama at Birmingham (UAB) |
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Per the clinical investigation protocol, IDE subjects (n=54) who did not consent to roll over into the post approval study (PAS) at sites participating in the post approval study, were included in primary endpoint analyses. Since these subjects are not enrolled into the PAS, they are not reflected in the participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Implanted With a New QuickFlex μ Lead | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years. |
| 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 | Yes | No | No | Study Protocol | Jun 10, 2010 | Feb 20, 2019 |
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| Birmingham |
| Alabama |
| 35294 |
| United States |
| Heart Center Research, LLC. | Huntsville | Alabama | 35801 | United States |
| Alaska Heart Institute | Anchorage | Alaska | 99508 | United States |
| Arizona Arrhythmia Research Center | Phoenix | Arizona | 85013 | United States |
| Arizona Arrhythmia Consultants | Scottsdale | Arizona | 85252 | United States |
| Arkansas Cardiology | Little Rock | Arkansas | 72205 | United States |
| St. Vincent Heart Clinic Arkansas | Little Rock | Arkansas | 72205 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Northwest Cardiology | Springdale | Arkansas | 72764 | United States |
| Glendale Memorial Hospital and Medical Center | Glendale | California | 91206 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Regional Cardiology Associates | Sacramento | California | 95819 | United States |
| University of California at San Diego (UCSD) Medical Center | San Diego | California | 92118 | United States |
| Claudio Bonometti MD, Inc | Santa Barbara | California | 93105 | United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA | Torrance | California | 90502 | United States |
| Christiana Hospital | Newark | Delaware | 19713 | United States |
| Shands Jacksonville | Jacksonville | Florida | 32209 | United States |
| Naushad Shaik, MD | Kissimmee | Florida | 32804 | United States |
| Munroe Regional Medical Center | Ocala | Florida | 34471 | United States |
| Usman R. Siddiqui, MD | Orlando | Florida | 32803 | United States |
| Orlando Heart Center | Orlando | Florida | 32806 | United States |
| Brevard Cardiovascular Research Associates, Inc. | Rockledge | Florida | 32955 | United States |
| University of South Florida, Cardiovascular Services | Tampa | Florida | 33606 | United States |
| Athens Regional Medical Center | Athens | Georgia | 30306 | United States |
| St. Joseph's Hospital | Atlanta | Georgia | 30045 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46805 | United States |
| The Heart Group | Newburgh | Indiana | 47630 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Mid-America Cardiology Associates, PC | Kansas City | Kansas | 66160 | United States |
| King's Daughters Medical Center | Ashland | Kentucky | 41101 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Norton Bluegrass Heart Specialists | Louisville | Kentucky | 40217 | United States |
| Peninsula Cardiology Associates, P.A. | Salisbury | Maryland | 21804 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Trinity Health-Michigan d/b/a Michigan Heart | Ann Arbor | Michigan | 48197 | United States |
| Thoracic Cardio Healthcare Found. (aka Sparrow Research) | Lansing | Michigan | 48912 | United States |
| MidMichigan Physicians Group | Midland | Michigan | 48640 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Cardiology Associates of North Mississippi | Tupelo | Mississippi | 38801 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Heart Consultants P.C. | Omaha | Nebraska | 68122 | United States |
| AtlantiCare Regional Medical Center | Pomona | New Jersey | 08240 | United States |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | 08043 | United States |
| New Jersey Cardiology Associates | West Orange | New Jersey | 07052 | United States |
| Lenox Hill Hospital | New York | New York | 10028 | United States |
| LeBauer HeartCare | Greensboro | North Carolina | 27401 | United States |
| Wake Forest University Medical Center Clinical Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Primed Cardiology/Kettering Medical Center Network | Kettering | Ohio | 45429 | United States |
| Regional Cardiovascular Medical Center | Steubenville | Ohio | 43953 | United States |
| The Toledo Hospital | Toledo | Ohio | 43615 | United States |
| Toledo Clinic | Toledo | Ohio | 43623 | United States |
| St. Elizabeth Health Center | Youngstown | Ohio | 44505 | United States |
| Providence Heart and Vascular Institute | Portland | Oregon | 97220 | United States |
| Tri-State Medical Group Cardiology | Beaver | Pennsylvania | 15009 | United States |
| Capital Cardiovascular Associates | Camp Hill | Pennsylvania | 17011 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Donald Guthrie Foundation for Education and Research | Sayre | Pennsylvania | 18840 | United States |
| WellSpan Health | York | Pennsylvania | 17405 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Cardiology Consultants | Johnson City | Tennessee | 37601 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| The Stern Cardiovascular Foundation | Memphis | Tennessee | 38120 | United States |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | United States |
| HeartPlace | Bedford | Texas | 76021 | United States |
| Advanced Heart Care | Plano | Texas | 75093 | United States |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | United States |
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| Cardiovascular Associates of East Texas | Tyler | Texas | 75701 | United States |
| McKay-Dee Heart Services | Ogden | Utah | 84403 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| Cardiovascular Associates Ltd | Chesapeake | Virginia | 23320 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| St. Mary's Hospital | Madison | Wisconsin | 53715 | United States |
| Cardiac Rhythm Specialists, S.C. | Milwaukee | Wisconsin | 53211 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Implanted With a New QuickFlex μ Lead | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years. |
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Left Ventricular Ejection Fraction | LVEF is percent of blood ejected from left ventricle | Mean | Standard Deviation | Percent of blood ejected |
| |||||||||||||||||||||
| Intrinsic QRS duration | Mean | Standard Deviation | ms |
| ||||||||||||||||||||||
| New York Heart Association (NYHA) Classification at Baseline | NYHA Functional Classification has 4 categories: Class I (least severe) - no limitation of physical activity Class II - slight limitation of physical activity Class III - marked limitation of physical activity Class IV (most severe) - unable to carry on any phyiscal activity without discomfort | Count of Participants | Participants |
| ||||||||||||||||||||||
| Cardiomyopathy | Count of Participants | Participants |
|
| 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 | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol). | The analysis population for Primary Endpoint #1 includes newly enrolled and IDE rollover subjects with an attempted implant of the QuickFlex μ LV lead (n=1,930) and subjects from the IDE sites that agreed to participate in the post-approval study, but did not consent to rollover into the post-approval study (n=54), for a total of 1,984 subjects. | Posted | Count of Participants | Participants | 5 years |
|
|
| ||||||||||||||||||||||||||
| Primary | Left Ventricular Bipolar Pacing Capture Threshold | Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up | Subjects included in this analysis are only those who have left ventricular bipolar pacing capture threshold values reported a the 5-year visit. Of the 843 who completed the 5 year visit, only 774 had analzable data. | Posted | Mean | Standard Deviation | Volts | 5 years |
|
|
Complications and observations post implant through 5 years
Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning).
An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)
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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 | Subjects Implanted With a New QuickFlex μ Lead | Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years. | 542 | 1,930 | 258 | 1,930 | 512 | 1,930 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead Dislodgement or Migration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Diaphragmatic/Phrenic Nerve Stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Loss of Capture | Product Issues | Systematic Assessment |
| ||
| Elevated Pacing Thresholds | Product Issues | Systematic Assessment |
| ||
| Abnormal LV Lead Pacing Impedance <= 200 OHMS or >= 2000 OHMS | Product Issues | Systematic Assessment |
| ||
| Dizziness | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Endocarditis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Induced Atrial or Ventricular Arrhythmias | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lead Fracture | Product Issues | Systematic Assessment |
| ||
| Lead Insulation Damage | Product Issues | Systematic Assessment |
| ||
| Pain/Discomfort At Incision Site | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Premature Battery Depletion | Product Issues | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment | Procedure Related |
| |
| Suspected Generator Malfunction | Product Issues | Systematic Assessment |
| ||
| Erosion | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| LV Lead Loss of Capture | Product Issues | Systematic Assessment |
| ||
| Twiddler Syndrome | Psychiatric disorders | Systematic Assessment |
| ||
| Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RA Lead Dislodgement or Migration | Product Issues | Systematic Assessment |
| ||
| RA Abnormal Lead Impedance | Product Issues | Systematic Assessment |
| ||
| RA Lead Insulation Damage | Product Issues | Systematic Assessment |
| ||
| RA Loss of Capture | Product Issues | Systematic Assessment |
| ||
| RA Atrial Lead Noise | Product Issues | Systematic Assessment |
| ||
| RA Cardiac/Coronary Sinus Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RA Diaphragmatic/Phrenic Nerve Stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RA Elevated Pacing Thresholds | Product Issues | Systematic Assessment |
| ||
| RA Oversensing | Product Issues | Systematic Assessment |
| ||
| RA Undersensing | Product Issues | Systematic Assessment |
| ||
| RV Lead Dislodgement or Migration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RV Elevated Pacing Thresholds | Product Issues | Systematic Assessment |
| ||
| RV Lead Fracture | Product Issues | Systematic Assessment |
| ||
| RV Lead Insulation Damage | Product Issues | Systematic Assessment |
| ||
| RV Abnormal Lead Impedance | Product Issues | Systematic Assessment |
| ||
| RV Cardiac/Coronary Sinus Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RV Loss of Capture | Product Issues | Systematic Assessment |
| ||
| RV Cardiac Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RV Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| RV Inappropriate Shock | Product Issues | Systematic Assessment |
| ||
| RV Infection | Infections and infestations | Systematic Assessment |
| ||
| RV Oversensing | Product Issues | Systematic Assessment |
| ||
| RV Pectoral Stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RV Lead Unable to Defibrillate | Product Issues | Systematic Assessment |
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| RV Undersensing | Product Issues | Systematic Assessment |
| ||
| Procedure Hematoma/Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Pneumothorax/Hemothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Cardiac/Coronary Sinus Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Cardiac Arrest | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Cardiac Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Deep Vein Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Device Migration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Guidewire Stuck In LV Lead | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Lead Dislodgement or Migration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Pleural Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural Skin Injury At PG Pocket | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LV Lead Elevated Pacing Thresholds | Product Issues | Systematic Assessment | LV Lead Related Observations |
| |
| LV Diaphragmatic/Phrenic Nerve Stimulation | Injury, poisoning and procedural complications | Systematic Assessment | LV Lead Related Observations |
| |
| LV Loss of Capture | Product Issues | Systematic Assessment | Lead Related Observations |
| |
| Abnormal LV Lead Pacing Impedance <= 200 Ω or >= 2000 Ω | Product Issues | Systematic Assessment | LV Lead Related Observations |
| |
| LV Induced Atrial or Ventricular Arrhythmias | Injury, poisoning and procedural complications | Systematic Assessment | LV Lead Related Observations |
| |
| LV Lead Dislodgement or Migration | Injury, poisoning and procedural complications | Systematic Assessment | LV Lead Related Observations |
| |
| LV Cardiac/Coronary Sinus Dissection | Injury, poisoning and procedural complications | Systematic Assessment | LV Lead Related Observations |
| |
| LV Coronary Sinus or Cardiac Vein Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment | LV Lead Related Observations |
| |
| LV Lead Insulation Damage | Product Issues | Systematic Assessment | LV Lead Related Observations |
| |
| System/Pulse Generator Related Therapy For Non-Ventricular Rhythm | Cardiac disorders | Systematic Assessment | (System / PG / Other Leads/ Procedure) |
| |
| System/Pulse Generator Related Failed ICD Shock | Product Issues | Systematic Assessment | System / PG / Other Leads/ Procedure |
| |
| System/Pulse Generator Related Idioventricular Rhythm Preventing Biventricular Pacing | Cardiac disorders | Systematic Assessment | System / PG / Other Leads/ Procedure |
| |
| System/Pulse Generator Related Pacemaker Mediated Tachycardia | Product Issues | Systematic Assessment | System / PG / Other Leads/ Procedure |
| |
| RA Lead Related Oversensing | Product Issues | Systematic Assessment |
| ||
| RA Lead Related Abnormal Lead Impedance | Product Issues | Systematic Assessment |
| ||
| RA Lead Related Atrial Lead Noise | Product Issues | Systematic Assessment |
| ||
| RA Lead Related Elevated Pacing Thresholds | Product Issues | Systematic Assessment |
| ||
| RA Lead Related Lead Insulation Damage | Product Issues | Systematic Assessment |
| ||
| RA Lead Related Loss of Capture | Product Issues | Systematic Assessment |
| ||
| RA Lead Related Lead Dislodgement or Migration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RA Lead Related Lead Fracture | Product Issues | Systematic Assessment |
| ||
| RA Lead Related Myopotential Sensing | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RA Lead Related Undersensing | Product Issues | Systematic Assessment |
| ||
| RV Lead Related Therapy For Non-Ventricular Rhythm | Cardiac disorders | Systematic Assessment |
| ||
| RV Lead Related Abnormal Lead Impedance | Product Issues | Systematic Assessment |
| ||
| RV Lead Related Lead Insulation Damage | Product Issues | Systematic Assessment |
| ||
| RV Lead Related Bilateral Pleural Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RV Lead Related Elevated Pacing Thresholds | Product Issues | Systematic Assessment |
| ||
| RV Lead Related Lead Externalization | Product Issues | Systematic Assessment |
| ||
| RV Lead Related Myopotential Sensing | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| RV Lead Related Oversensing | Product Issues | Systematic Assessment |
| ||
| RV Lead Related Pectoral Stimulation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Hematoma/Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Cardiac/Coronary Sinus Dissection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Infection | Infections and infestations | Systematic Assessment |
| ||
| Procedure Related Atrial Arrhythmia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Bleeding And/or Hemoptysis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Cardiac Vein Thrombus | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Part of The Delivery Tool Was Left In The Coronary Sinus/ Ventricle | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Pneumothorax/Hemothorax | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Pulmonary Edema | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Renal Failure or Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Acute Left Arm Thrombophlebitis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Cardiac/Coronary Sinus Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Decompensated Heart Failure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Device Incision Erythema | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Excessive Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Frozen Shoulder | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related High DFT's | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Hypotension Requiring Medical Intervention During CRT-D Implant | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Myocardial Infarction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedure Related Pericarditis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other Therapy For Non-Ventricular Rhythm | Cardiac disorders | Systematic Assessment |
| ||
| Other Pericardial Effusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other Induced Atrial or Ventricular Arrhythmias | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other Pulmonary Edema | General disorders | Systematic Assessment |
| ||
| Other Infection | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn, Clinical Program Director | Abbott | 972-309-8087 | clay.cohorn@abbott.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Black or African American |
|
| Hispanic or Latino |
|
| Native Hawaiian/Pacific Islander |
|
| Other |
|
| White |
|
| Class III |
|
| Class IV |
|
| Unknown |
|
|