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The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
This study design consists of PIIS3i cohort.
The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access.
To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIIS3i - SAPIEN 3 | Experimental | PIIS3i - SAPIEN 3 is Operable Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR | Device | Implantation of the SAPIEN 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days | 30 Days |
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Inclusion Criteria
Exclusion Criteria:
Heart team assessment of inoperability (including examining cardiac surgeon).
Complex coronary artery disease
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.
Need for emergency surgery for any reason.
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| Name | Affiliation | Role |
|---|---|---|
| Martin B Leon, MD | Columbia University | Principal Investigator |
| Craig Smith, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42300820 | Derived | Nazif TM, Simonato M, Makkar RR, Thourani VH, Desai ND, Babaliaros V, Greason K, Rovin J, Waxman S, Davidson C, Kereiakes DJ, Gupta A, Satler L, Schwartz R, Kapadia S, Wong SC, Smalling RW, Ghani M, Teirstein P, George I, Potluri S, Szerlip M, Xu K, Cohen DJ, Sharma RP, Pibarot P, Hahn RT, Mack MJ, Leon MB; PARTNER 2 Investigators. 10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients. J Am Coll Cardiol. 2026 Jun 16;87(23):3296-3308. doi: 10.1016/j.jacc.2026.03.170. | |
| 37407110 |
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The As-Treated population was 1074 The Valve-Implanted population was 1069
Subjects were screened and enrolled at 51 sites in the US
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| ID | Title | Description |
|---|---|---|
| FG000 | PIIS3i - SAPIEN 3 | PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Los Angeles |
| California |
| 90048 |
| United States |
| Mercy General Hospital | Sacramento | California | 95816 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| University of Colorado Hospital | Denver | Colorado | 80045 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| University of Florida | Gainesville | Florida | 32615 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Northshore | Evanston | Illinois | 60201 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | United States |
| Indiana University Health-Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC | Indianapolis | Indiana | 46290 | United States |
| The University of Iowa | Iowa City | Iowa | 52242 | United States |
| The Jewish Hospital Medical Center | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic-Saint Marys Hospital | Rochester | Minnesota | 55905 | United States |
| St. Luke's Hospital - Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| Washington University - Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Northshore Long Island Jewish Health System | New Hyde Park | New York | 11040 | United States |
| Cornell University | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke University | Durham | North Carolina | 27712 | United States |
| East Carolina Heart Institute at East Carolina University | Greenville | North Carolina | 27834 | United States |
| The Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | 73120 | United States |
| Providence Heart & Vascular Institute at Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Austin Heart, PLLC | Austin | Texas | 78756 | United States |
| The Heart Hospital Baylor Plano | Dallas | Texas | 75093 | United States |
| Medical City Dallas | Dallas | Texas | 75230 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio (UTHSCSA) | San Antonio | Texas | 78229-3900 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| Derived |
| Madhavan MV, Kodali SK, Thourani VH, Makkar R, Mack MJ, Kapadia S, Webb JG, Cohen DJ, Herrmann HC, Williams M, Greason K, Pibarot P, Hahn RT, Jaber W, Xu K, Alu M, Smith CR, Leon MB. Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2023 Jul 11;82(2):109-123. doi: 10.1016/j.jacc.2023.04.049. |
| 35041482 | Derived | Vincent F, Thourani VH, Ternacle J, Redfors B, Cohen DJ, Hahn RT, Li D, Crowley A, Webb JG, Mack MJ, Kapadia S, Russo M, Smith CR, Alu MC, Leon MB, Pibarot P. Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials. Circ Cardiovasc Qual Outcomes. 2022 Jan;15(1):e007948. doi: 10.1161/CIRCOUTCOMES.121.007948. Epub 2022 Jan 18. |
| 34130476 | Derived | Herrmann HC, Cohen DJ, Hahn RT, Babaliaros VC, Yu X, Makkar R, McCabe J, Szerlip M, Kapadia S, Russo M, Malaisrie SC, Webb JG, Szeto WY, Kodali S, Thourani VH, Mack MJ, Leon MB. Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2021 Jul;14(7):e010310. doi: 10.1161/CIRCINTERVENTIONS.120.010310. Epub 2021 Jun 16. |
| 33754803 | Derived | Brener MI, George I, Kosmidou I, Nazif T, Zhang Z, Dizon JM, Garan H, Malaisrie SC, Makkar R, Mack M, Szeto WY, Fearon WF, Thourani VH, Leon MB, Kodali S, Biviano AB. Atrial Fibrillation Is Associated With Mortality in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: Analyses From the PARTNER 2A and PARTNER S3i Trials. J Am Heart Assoc. 2021 Apr 6;10(7):e019584. doi: 10.1161/JAHA.120.019584. Epub 2021 Mar 23. |
| 33334422 | Derived | Ong G, Pibarot P, Redfors B, Weissman NJ, Jaber WA, Makkar RR, Lerakis S, Gopal D, Khalique O, Kodali SK, Thourani VH, Anwaruddin S, McAndrew T, Zhang Y, Alu MC, Douglas PS, Hahn RT. Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry. J Am Coll Cardiol. 2020 Dec 22;76(25):2940-2951. doi: 10.1016/j.jacc.2020.10.032. |
| 33059828 | Derived | Pibarot P, Ternacle J, Jaber WA, Salaun E, Dahou A, Asch FM, Weissman NJ, Rodriguez L, Xu K, Annabi MS, Guzzetti E, Beaudoin J, Bernier M, Leipsic J, Blanke P, Clavel MA, Rogers E, Alu MC, Douglas PS, Makkar R, Miller DC, Kapadia SR, Mack MJ, Webb JG, Kodali SK, Smith CR, Herrmann HC, Thourani VH, Leon MB, Hahn RT; PARTNER 2 Investigators. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial. J Am Coll Cardiol. 2020 Oct 20;76(16):1830-1843. doi: 10.1016/j.jacc.2020.08.049. |
| 31883339 | Derived | Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892. |
| 31690104 | Derived | Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6. |
| 31525069 | Derived | Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1. |
| 31505615 | Derived | Nazif TM, Chen S, George I, Dizon JM, Hahn RT, Crowley A, Alu MC, Babaliaros V, Thourani VH, Herrmann HC, Smalling RW, Brown DL, Mack MJ, Kapadia S, Makkar R, Webb JG, Leon MB, Kodali SK. New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial. Eur Heart J. 2019 Jul 14;40(27):2218-2227. doi: 10.1093/eurheartj/ehz227. |
| Valve-Implanted |
|
| COMPLETED | One year follow-up |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PIIS3i - SAPIEN 3 | PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3 |
| 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 |
| ||||||||||||||||||
| STS Score | The Society of Thoracic Surgeons (STS) Score measures patient risk of mortality or morbidity at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| NYHA Classification III/IV | New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-V, with the lowest as no limitations and highest unable to carry on any physical activity without discomfort. | 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 | Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate | AI as a factor in this value; only 964/1069 patients had ECHO data. | Posted | Count of Participants | Participants | 1 year |
|
|
| |||||||||||||||||||||||||||
| Secondary | Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days | Posted | Count of Participants | Participants | 30 Days |
|
|
|
The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
All Adverse Events are site-reported.
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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 | PIIS3i - SAPIEN 3 | PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3 | 75 | 1,069 | 592 | 1,069 | 861 | 1,069 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal lab value | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Dissection | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Distal embolization (noncerebral) from vascular sou | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Failure of percutaneous access site closure | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | resulting in intervention |
|
| Access site and access related vascular injury - Hematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Other | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Perforation | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Pseudoaneurysm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Rupture | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Stenosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Access site and access related vascular injury - Ventricular rupture (Apical rupture) | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anemia/Hemolytic anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anesthesia related complication - Confusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Anesthesia related complication - Other | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Angina/Cardiac chest pain | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Aortic Valve Stenosis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Aortic insufficiency/Regurgitation PV leak - Structural dysfunction | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Aortic insufficiency/Regurgitation non valvular cause | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Arrhythmia/Conduction system injury (defect) | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bleeding - Hemorrhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac tamponade/Pericardial effusion | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Coronary artery disease/Coronary ischemia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Coronary flow obstruction/Transvalvular flow disturbance | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Device migration/malposition requiring intervention | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Edema | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Exercise intolerance or weakness | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastro Intestinal event - Non-hemorrhagic | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Genito-Urinary event - Non-hemorrhagic | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Heart failure/CHF/Low output failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemolysis | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Access site infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Bacteremia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Endocarditis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Other | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Respiratory infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Ischemia | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Mental state change (not neurological) - Confusion | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Mental state change (not neurological) - Dementia | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Mental state change (not neurological) - Depression | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Miscellaneous - Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Miscellaneous - Drug reaction | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Miscellaneous - Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Miscellaneous - Other | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Miscellaneous - Suicide | Social circumstances | MedDRA (10.0) | Systematic Assessment |
| |
| Mitral valve injury or insufficiency | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Multi organ failure | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal - Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal - Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Change in level of consciousness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Cognitive impairment | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Dysphasia/Aphasia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Hemiparesis (One sided body weakness) | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Hemorrhagic stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Ischemic stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Other | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Other new neurological sign consistent with stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - TIA | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neurological - Undetermined stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Renal insufficiency or renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Other | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Pulmonary effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Unknown cause of death | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Valve thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vascular complication - Non-access related | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Other | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal lab value | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Anemia/Hemolytic anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Arrhythmia/Conduction system injury (defect) | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bleeding - Hemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastro Intestinal event - Non-hemorrhagic | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Genito-Urinary event - Non-hemorrhagic | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Heart failure/CHF/Low output failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Other | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Infection - Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Miscellaneous - Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Miscellaneous - Other | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Musculoskeletal - Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Renal insufficiency or renal failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory event - Pulmonary effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Other | Investigations | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Edwards Lifesciences | 949-250-2500 | THV_CT.gov@Edwards.com |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
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