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The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of the Trifecta™ aortic bioprosthetic valve. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supraannular placement in the aortic position. The Trifecta™ LTFU Study is an extension of the Trifecta™ Investigational Device Exemption (IDE) Study (NCT00475709) conducted to support United States Food and Drug Administration (FDA) approval of the Trifecta™ valve. All Trifecta™ LTFU Study subjects received Trifecta™ valve implants during participation in the Trifecta™ IDE study and subsequently consented to extended annual follow-up through 10 years under the Trifecta™ LTFU protocol.
This clinical study was designed as an extension of the Trifecta™ IDE Study supporting FDA approval of the Trifecta™ valve. A total of 11 Trifecta™ IDE Study investigational sites in the United States (n=9) and Canada (n=2) participated in the Trifecta™ LTFU Study. Study enrollment included 329 subjects implanted from 2007 through 2009 at these 11 sites during the IDE Study who consented to participate in continued annual follow-up through 10 years post-implant. Of these 329 subjects, 140 also participated in the FDA-mandated Trifecta™ Post-Approval Study (PAS, NCT01514162) prior to consenting to additional annual follow-up under the Trifecta™ LTFU protocol. The remaining 189 subjects entered the Trifecta™ LTFU Study directly from the Trifecta™ IDE Study.
The Trifecta™ LTFU Study database subsumes all data collected in the 329 participants under the Trifecta™ IDE and Trifecta™ PAS protocols and extends these data through 10 years from each subject's original date of implant in the Trifecta™ IDE Study. The Trifecta™ LTFU Study data thus encompass 10 years of continuous annual post-implant follow-up in the 329 participants as well as their pre-implant Baseline Visit data. Data collected includes adverse events, assessments of heart failure symptoms by New York Heart Association (NYHA) functional classification, and echocardiographic assessments of Trifecta™ valve function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects previously implanted with a Trifecta™ valve in the Trifecta™ IDE Study | Subjects enrolled in this clinical study were implanted with the Trifecta™ aortic bioprosthetic valve during 2007, 2008 and 2009 as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifecta™ Valve | Device | Aortic valve replacement with the Trifecta™ aortic bioprosthesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant | Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve implantation for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. | 10 years post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant | Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator. | 10 years post-implant |
| Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Late adverse events are defined those occurring from 31 days through 10 years post-implant. This outcome measure is calculated by dividing the number of late adverse events of each type by the total number of patient-years of follow-up accumulated from 31 days through 10 years post-implant, expressed in hundreds of years. | 31 days through 10 years post-implant |
Inclusion Criteria:
Exclusion Criteria:
1. Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.
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Subjects previously implanted with a Trifecta prosthetic valve
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| Name | Affiliation | Role |
|---|---|---|
| Barathi Sethuraman | Abbott Structural Heart | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC University Hospital | Los Angeles | California | 90033 | United States | ||
| Abbott Northwestern Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23477687 | Background | Bavaria JE, Desai ND, Cheung A, Petracek MR, Groh MA, Borger MA, Schaff HV. The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014 Feb;147(2):590-7. doi: 10.1016/j.jtcvs.2012.12.087. Epub 2013 Mar 7. | |
| 27964975 | Background |
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The 329 subjects participated in the pre-market Trifecta™ IDE Study used to obtain Food and Drug Administration (FDA) approval. Thereafter, they consented to extended follow-up in the Trifecta™ LTFU Study. Additionally, 140 of the 329 participated in the FDA-required Trifecta™ Post-Approval Study (PAS, NCT01514162) before entering the LTFU Study. Trifecta™ LTFU data subsume the 329 subjects' data from the IDE and PAS protocols and extend these data through 10-years from Trifecta™ implant.
A total of 329 subjects were enrolled into the Trifecta™ Long Term Follow-Up (LTFU) Study at 11 sites in the United States and Canada. All 329 subjects had received Trifecta™ implants in 2007, 2008 and 2009 during their participation in the Trifecta™ Investigational Device Exemption Study (IDE) Study (NCT00475709). Trifecta™ LTFU study enrollments occurred between 02 July, 2012 and 27 March, 2017. The final 10-years post-Trifecta™-implant follow-up visit was completed on 26 September, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Previously Implanted With a Trifecta™ Valve | Subjects enrolled in this clinical study received the Trifecta™ valve during the Trifecta™ IDE Study conducted to obtain FDA approval. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Previously Implanted With a Trifecta™ Valve | Subjects enrolled in this clinical study were implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study conducted to obtain FDA approval. Baseline data are from the pre-implant Baseline and Implant Visits in the Trifecta™ IDE Study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant | Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve implantation for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. | Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 10 years post-implant |
|
10 Years
Adverse event data collection includes all serious adverse events recorded in each participant from the time of their Trifecta™ implant under the Trifecta™ IDE study in 2007, 2008 and 2009 through the end of the Trifecta™ LTFU study in 2019. Non-serious adverse event data were not collected.
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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 Previously Implanted With a Trifecta Valve | Subjects enrolled in this clinical study received the Trifecta valve during the investigational study that was conducted to obtain FDA approval. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist, Tissue Heart Valves | Abbott Medical Devices, Structural Heart Divison | +1 651-756-2320 | Roland.MaudeGriffin@Abbott.com |
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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 | Jan 9, 2012 | Dec 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality. |
| 10 years post-implant |
| Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant | Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation. | 10 years post-implant |
| Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | Average of participants' mean aortic transvalvular pressure gradient measured by echocardiography at 10 years post-implant. Averages are reported for each valve size separately. The mean transvalvular pressure gradient is the mean difference in pressure between the inlet side and outlet side of the aortic valve during systole, measured in millimeters of mercury (mmHg). | 10 years post-implant |
| Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve estimated by echocardiography. Mean EOA in square centimeters is reported separately for each valve size. | 10 years post-implant |
| Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | Regurgitation occurs when the aortic valve does not fully seal, allowing backflow of blood through the closed valve. The amount of aortic regurgitation in this study was graded as none, trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe aortic regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance. | 10 years post-implant |
| Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | The New York Heart Association (NYHA) functional classification system relates heart failure symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Preoperative through 10 years |
| Minneapolis |
| Minnesota |
| 55407 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mission Health & Hospitals | Asheville | North Carolina | 28801 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Main Line Health Center/Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Intermountain Salt Lake Cardiovascular and Thoracic Surgery | Salt Lake City | Utah | 84103 | United States |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Institut de Cardiologie de Quebec (Hôpital Laval) | Québec | G1V 4G5 | Canada |
| Goldman S, Cheung A, Bavaria JE, Petracek MR, Groh MA, Schaff HV. Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve. J Thorac Cardiovasc Surg. 2017 Mar;153(3):561-569.e2. doi: 10.1016/j.jtcvs.2016.09.089. Epub 2016 Nov 18. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Physician Decision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preoperative New York Heart Association (NYHA) functional classification III or IV | NYHA functional classification is a widely used four class ( I, II, III, and IV) measure of the severity of heart failure symptoms. Class I and II patients experience no or slight limitations on their physical activity. Class III and IV patients experience marked limitations on their physical activity or are unable to perform any physical activity without discomfort. | Count of Participants | Participants |
|
| History of Coronary Artery Disease | Count of Participants | Participants |
|
| History of Hypertension | Count of Participants | Participants |
|
| History of Diabetes | Count of Participants | Participants |
|
| History of Smoking | Count of Participants | Participants |
|
| Preoperative Coumarin Derivatives | Coumarin derivatives are anticoagulant medications prescribed to patients at high risk of forming blood clots that can block critical blood vessels. The most widely used coumarin derivative medication is warfarin. | Count of Participants | Participants |
|
| Preoperative Aspirin | Count of Participants | Participants |
|
| Preoperative Antiplatelet Medication | Count of Participants | Participants |
|
| Previous Cardiovascular Surgery/Procedure | Count of Participants | Participants |
|
| No Concomitant Procedure | Count of Participants | Participants |
|
| Concomitant Coronary Artery Bypass Grafting (CABG) | Count of Participants | Participants |
|
| Cardiopulmonary Bypass Time (minutes) | Mean | Standard Deviation | minutes |
|
| Aortic Cross Clamp Time (minutes) | Mean | Standard Deviation | minutes |
|
| Implanted Valve Size | Count of Participants | Participants |
|
Subjects enrolled in this clinical study were implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study conducted to obtain FDA approval. |
|
|
| Secondary | Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant | Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator. | Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 10 years post-implant |
|
|
|
| Secondary | Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant | Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality. | Analysis population includes participants implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study who consented to be enrolled in this study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 10 years post-implant |
|
|
|
| Secondary | Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant | Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation. | Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 10 years post-implant |
|
|
|
| Other Pre-specified | Number of Late Adverse Events Per 100 Patient-Years of Follow-up | Late adverse events are defined those occurring from 31 days through 10 years post-implant. This outcome measure is calculated by dividing the number of late adverse events of each type by the total number of patient-years of follow-up accumulated from 31 days through 10 years post-implant, expressed in hundreds of years. | Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study. | Posted | Number | Number of events per 100 patient-years | 31 days through 10 years post-implant |
|
|
|
| Other Pre-specified | Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size | Average of participants' mean aortic transvalvular pressure gradient measured by echocardiography at 10 years post-implant. Averages are reported for each valve size separately. The mean transvalvular pressure gradient is the mean difference in pressure between the inlet side and outlet side of the aortic valve during systole, measured in millimeters of mercury (mmHg). | Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study and who have 10-year mean gradient data. | Posted | Mean | Standard Deviation | mmHg | 10 years post-implant |
|
|
|
| Other Pre-specified | Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve estimated by echocardiography. Mean EOA in square centimeters is reported separately for each valve size. | Analysis population includes participants implanted with the Trifecta™ valve as part of the Trifecta™ IDE Study who consented to be enrolled in this study and who have EOA data available at 10 years post-implant. | Posted | Mean | Standard Deviation | square centimeters | 10 years post-implant |
|
|
|
| Other Pre-specified | Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant | Regurgitation occurs when the aortic valve does not fully seal, allowing backflow of blood through the closed valve. The amount of aortic regurgitation in this study was graded as none, trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe aortic regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance. | Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study and who have aortic regurgitation assessment data available at 10 years post-implant. | Posted | Count of Participants | Participants | 10 years post-implant |
|
|
|
| Other Pre-specified | Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant | The New York Heart Association (NYHA) functional classification system relates heart failure symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Analysis population includes participants implanted with the Trifecta™ valve in 2007, 2008 and 2009 as part of the Trifecta™ IDE Study who consented to be enrolled in this study and have available Preoperative and/or 10-year NYHA classification data. | Posted | Count of Participants | Participants | Preoperative through 10 years |
|
|
|
| 67 |
| 329 |
| 272 |
| 329 |
| 0 |
| 0 |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
|
| Major Bleeding | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
|
| Cardiac Arrhythmias | Cardiac disorders | MedDRA (11) | Systematic Assessment |
|
| Endocarditis | Cardiac disorders | MedDRA (11) | Systematic Assessment |
|
| Heart Failure Signs and Symptoms | Cardiac disorders | MedDRA (11) | Systematic Assessment |
|
| Mitral Regurgitation | Cardiac disorders | MedDRA (11) | Systematic Assessment |
|
| Myocardial Ischemia | Cardiac disorders | MedDRA (11) | Systematic Assessment |
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| Paravalvular Leak | Cardiac disorders | MedDRA (11) | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA (11) | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (11) | Systematic Assessment |
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| Structural Valve Deterioration, Explanted | Cardiac disorders | MedDRA (11) | Systematic Assessment |
|
| Structural Valve Deterioration, Transcatheter Valve-in-Valve Implant | Cardiac disorders | MedDRA (11) | Systematic Assessment |
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| Structural Valve Deterioration without Reintervention | Cardiac disorders | MedDRA (11) | Systematic Assessment |
|
| Valve Thrombosis | Cardiac disorders | MedDRA (11) | Systematic Assessment |
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| Diabetic Hyperglycemia | Endocrine disorders | MedDRA (11) | Systematic Assessment |
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| Thyroid Disorders | Endocrine disorders | MedDRA (11) | Systematic Assessment |
|
| Eye Disorders | Eye disorders | MedDRA (11) | Systematic Assessment |
|
| Abdominal Hernias | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
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| Appendicitis | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
|
| Esophageal Disorders | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
|
| Vomiting, Diarrhea, Constipation | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
|
| Intestinal Disorders | Gastrointestinal disorders | MedDRA (11) | Systematic Assessment |
|
| Death from Unknown Causes | General disorders | MedDRA (11) | Systematic Assessment |
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| Dehydration | General disorders | MedDRA (11) | Systematic Assessment |
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| Dizziness | General disorders | MedDRA (11) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (11) | Systematic Assessment |
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| Headache | General disorders | MedDRA (11) | Systematic Assessment |
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| Heat Stroke | General disorders | MedDRA (11) | Systematic Assessment |
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| Hematoma | General disorders | MedDRA (11) | Systematic Assessment |
|
| Event Classification Unknown | General disorders | MedDRA (11) | Systematic Assessment |
|
| Biliary Obstruction | Hepatobiliary disorders | MedDRA (11) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (11) | Systematic Assessment |
|
| Bacteremia or Septicemia | Infections and infestations | MedDRA (11) | Systematic Assessment |
|
| Lower Respiratory Tract And Lung Infections | Infections and infestations | MedDRA (11) | Systematic Assessment |
|
| Wound Infections | Infections and infestations | MedDRA (11) | Systematic Assessment |
|
| Abdominal Abscess | Infections and infestations | MedDRA (11) | Systematic Assessment |
|
| Joint Disorders | Musculoskeletal and connective tissue disorders | MedDRA (11) | Systematic Assessment |
|
| Benign Lesions | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11) | Systematic Assessment |
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| Malignancies | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11) | Systematic Assessment |
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| Delerium | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Siezure Disorders | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Concussion | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA (11) | Systematic Assessment |
|
| Renal Disorders | Renal and urinary disorders | MedDRA (11) | Systematic Assessment |
|
| Urinary Tract Disorders | Renal and urinary disorders | MedDRA (11) | Systematic Assessment |
|
| Reproductive System and Breast Disorders | Reproductive system and breast disorders | MedDRA (11) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (11) | Systematic Assessment |
|
| Lacerations or Contusions | Skin and subcutaneous tissue disorders | MedDRA (11) | Systematic Assessment |
|
| Rashes, Eruptions And Exanthems | Skin and subcutaneous tissue disorders | MedDRA (11) | Systematic Assessment |
|
| Aortic Artery Disease | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Carotid Artery Disease | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Peripheral Arterial Disease | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Thromboembolism | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
|
| Air Embolism | Vascular disorders | MedDRA (11) | Systematic Assessment |
|
| Minor Bleeding | Blood and lymphatic system disorders | MedDRA (11) | Systematic Assessment |
|
| Clostridium Difficile Infection | Infections and infestations | MedDRA (11) | Systematic Assessment |
|
| Foot Abscess | Infections and infestations | MedDRA (11) | Systematic Assessment |
|
| Klebsiella Infections | Infections and infestations | MedDRA (11) | Systematic Assessment |
|
| Fractures | Musculoskeletal and connective tissue disorders | MedDRA (11) | Systematic Assessment |
|
| Tendon, Ligament and Cartilage Disorders | Musculoskeletal and connective tissue disorders | MedDRA (11) | Systematic Assessment |
|
| Confusion | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Guillain-Barré Syndrome | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Peripheral Neuropathy | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (11) | Systematic Assessment |
|
| Respiratory Tract Signs and Symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
|
| Chronic Respiratory Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
|
| Barotrauma | Respiratory, thoracic and mediastinal disorders | MedDRA (11) | Systematic Assessment |
|
Not provided
Not provided
| D014694 |
| Ventricular Outflow Obstruction |
| Title | Measurements |
|---|---|
|
| Reoperation for SVD (surgical explant or transcatheter valve-in-valve implant) |
|
| Thromboembolism |
|
| Valve Thrombosis |
|
| Major Bleeding |
|
| Major Paravalvular Leak |
|
| Endocarditis |
|
|
| 23 mm |
|
|
| 25 mm |
|
|
| 27 mm |
|
|
| 29 mm |
|
|
|
| 23 mm |
|
|
| 25 mm |
|
|
| 27 mm |
|
|
| 29 mm |
|
|
| Title | Measurements |
|---|
|
| Moderate |
|
| Severe |
|
| NYHA Class III |
|
| NYHA Class IV |
|
| 10 Years |
|
|