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To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Failing surgical valve | Experimental | Patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards SAPIEN XT transcatheter valve, Model 9300TFX | Device | Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) | The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mortality From Any Cause | Cardiovascular cause is also included | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Webb, MD | St. Paul's Hospital, Vancouver, British columbia, Canada | Principal Investigator |
| Michael Mack, MD | Baylor Heart Hospital, Plano, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Scripps Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35656983 | Derived | Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3. | |
| 31146808 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Edwards SAPIEN XT THV in Patients With Failing SAVR | Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve. Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| La Jolla |
| California |
| 92037 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| University of Colorado Hospital | Denver | Colorado | 80045 | United States |
| Washington Hospital Center (WHC) | Washington D.C. | District of Columbia | 20010 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University Hospital | Atlanta | Georgia | 30341 | United States |
| Northwestern Hospital | Chicago | Illinois | 60611 | United States |
| NorthShore University HealthSystem Research Institute | Evanston | Illinois | 60201 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | United States |
| The University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Louisville Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48130 | 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 |
| Saint Luke's Hospital of Kansas City Mid America | 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 |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Winthrop-University Hospital | Mineola | New York | 11501 | United States |
| Cornell University | New York | New York | 10021 | United States |
| Columbia University Medical Center/ New York Presbyterian Hospital | New York | New York | 10032 | United States |
| East Carolina Heart Institute at East Carolina University | Greenville | North Carolina | 27834 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73135 | United States |
| Providence St.Vincent Medical Center | Portland | Oregon | 97225 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The Heart Hospital Baylor Plano | Dallas | Texas | 75093 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Salt Lake City | 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 | 98101 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| St. Paul's Hospital, Providence Health Care | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Derived |
| Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483. |
| Valve-Implanted |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Edwards SAPIEN XT THV in Patients With Failing SAVR | Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve. Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems. |
| 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 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 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 - IV, with the lowest as no limitations and the 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 All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite) | The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak | Twenty-nine patients had missing echocardiography data. | Posted | Count of Participants | Participants | 30-day |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Mortality From Any Cause | Cardiovascular cause is also included | Posted | Count of Participants | Participants | 30 Days |
|
|
30-day
Site reported events Only Valve-Implant patients are analyzed.
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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 | Edwards SAPIEN XT THV in Patients With Failing SAVR | Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve. Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems. | 8 | 195 | 109 | 195 | 142 | 195 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Lab Value | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Anemia/Hemolytic Anemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina/Cardiac Chest Pain | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia/Conduction System Injury (Defect) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Change in level of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Compartment syndrome | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Coronary Flow Obstruction/Transvalvular flow disturbance | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Embolization including air/calcific valve material or Thrombus | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Failure of percutaneous access site closure resulting in intervention | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Gastro Intestinal Event | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastro Intestinal Event Nonhemorrhagic | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Genito Urinary Event | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Genito Urinary Event Nonhemorrhagic | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Heart Failure / CHF / Low output Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Hemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hemorrhagic Stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ischemic Stroke | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Mitral Valve Injury or Insufficiency | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Multi Organ Failure | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Non Structural Dysfunction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Pain | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Perforation | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pseudoaneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Restenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Rupture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Syncope | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Unknown cause of Death | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Other | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Undetermined Stroke | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| TIA | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Confusion | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Access site infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Dementia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Device Migration/malposition requiring intervention | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Drug Reaction | Investigations | 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 | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia/Conduction System Injury (Defect) | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Heart Failure / CHF / Low output Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Insufficiency or Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Other | Investigations | MedDRA 10.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwards THV Clinical Affairs | Edwards Lifesciences | (949) 250-2500 | THV_CT.gov@Edwards.com |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D002312 | Cardiomyopathy, Hypertrophic |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
| D014652 | Vascular Diseases |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|