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A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XTâ„¢ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendraâ„¢ transapical delivery system, and crimper accessories.
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XTâ„¢ study valve and next generation Ascendraâ„¢ delivery components.
Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR-TA | Experimental | Transcatheter valve replacement with transapical access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAPIEN XTâ„¢ Transapical aortic valve replacement | Device | Transcatheter aortic valve implantation via the transapical approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Deaths | Number of death at 30-days from the index procedure. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Stroke | Total Number of Participants with a Stroke. | 30-days |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Thomas Walther | Kerckhoff Klinik | Principal Investigator |
| Dr. Olaf Wendler | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitat Wien Univ.Klinik f.Chirurgie | Vienna | 1019 | Austria | |||
| Hôspital Bichat |
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Two enrolled subjects did not enter the procedure room.
One patient withdrew from the study prior to procedure and one patient did not continue to procedure due to poor health.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAVR-TA | Transcatheter valve replacement with transapical access SAPIEN XTâ„¢ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paris |
| 75018 |
| France |
| Herz-Und Gefasszentrum Bad Bevensen | Bad Bevensen | 29549 | Germany |
| Kerckhoff-Klinik | Bad Nauheim | 61231 | Germany |
| Herz-und-Gefass Klinik | Bad Neustadt an der Saale | 97616 | Germany |
| Herz-und Diabeteszentrum NRW | Bad Oeynhausen | 32545 | Germany |
| Schüchtermann-Klinik | Bad Rothenfelde | 49214 | Germany |
| Heart Center University Cologne | Cologne | 50924 | Germany |
| Herzzentrum Dresden GmbH | Dresden | 01307 | Germany |
| University Clinic Erlangen | Erlangen | 91054 | Germany |
| University Hospital Essen, West German Heart Center | Essen | 45122 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Cardiac Surgery Karlsruhe | Karlsruhe | 76185 | Germany |
| Heart Center Leipzig | Leipzig | 04829 | Germany |
| German Heart Center Munich | Munich | 80636 | Germany |
| University Hospital Munich-Grosshadern | Munich | 81377 | Germany |
| Hospital Munich-Bogenhausen | Munich | 81925 | Germany |
| Robert-Bosch-Krankenhaus | Stuttgart | 70376 | Germany |
| St. Thomas' Hospital - NHS Trust | London | SE1 7EH | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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As treated population
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| ID | Title | Description |
|---|---|---|
| BG000 | TAVR-TA | Transcatheter valve replacement with transapical access SAPIEN XTâ„¢ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Logistic EuroSCORE | The logistic European System for Cardiac Operative Risk Evaluation (logistic EuroSCORE) 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 of operative mortality. | Mean | Standard Deviation | Units on a scale |
| |||||||||||||||||
| NYHA Class | 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. I = no limitations of physical activity; II = slight limitations of physical activity, ordinary physical activity results in fatigue, palpitation, shortness of breath; III = marked limitations of physical activity, less than ordinary activity causes fatigue, palpitation, or shortness of breath.; IV = unable to carry on any physical activity without discomfort, symptoms of heart failure at rest. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Deaths | Number of death at 30-days from the index procedure. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Number of Participants With a Stroke | Total Number of Participants with a Stroke. | Posted | Count of Participants | Participants | 30-days |
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5 Years
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 | TAVR-TA | Transcatheter valve replacement with transapical access SAPIEN XTâ„¢ Transapical aortic valve replacement: Transcatheter aortic valve implantation via the transapical approach | 124 | 218 | 201 | 218 | 212 | 218 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Related Complication - Thoracic | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Access Related Complication - Ventricle | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Aneurysm | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Angina | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Annular Dissection | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Arrhythmia Supraventricular | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Arrhythmia Ventricular | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Bleeding - Not Trauma Not Procedure | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Bleeding - Procedure | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Bleeding - Trauma | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
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| Coagulopathy / Hematological Disorder | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Conduction Defects w/o Permanent Pacemaker | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Conduction Defects with Permanent Pacemaker | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Decubitus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
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| Delivery System Malfunction | Product Issues | MedDRA (23.0) | Systematic Assessment |
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| Drug Reaction | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Gastro-Intestinal Event | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Heart Failure | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Hemodynamic Collapse | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Infection / Inflammation | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Metabolic Disorder | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| Mitral Regurg. ( 3+ or 4+) | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Mitral Valve Compromise | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Multiple Organ Failure | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Neurological Event Minor - Not Stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Neurological Event Severe - Not Stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Non-Struct Valve Dysf. (Not PVL) | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Orthopedic Event | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Other | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Perivalvular Leak (1+ or 2+) | Product Issues | MedDRA (23.0) | Systematic Assessment |
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| Perivalvular Leak (3+ or 4+) | Product Issues | MedDRA (23.0) | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Renal Failure requiring Permanent Dialysis (>30d) | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| Renal Insufficency not requiring Dialysis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| Renal Insufficiency / Failure requiring Temporary Dialysis (< or = 30d) | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| Respiratory Comp / Failure not requ. Resp Assistance | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Respiratory Comp / Failure requ. Resp Assistance | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Stroke - Embolic / Ischemic Origin | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Stroke - Unknown Origin | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Struct Valve Deterioration (SVD) | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Sudden Death | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Thoracic Wound Comp. | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Thrombus | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Transitory Psychotic Syndrome | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
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| Valve Embolization | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Vascular Event (Not Access-Related) | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Ventricular / Myocardial Injury / Perforation | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Vision Disorder | Eye disorders | MedDRA (23.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia Supraventricular | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Bleeding - Procedure | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
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| Coagulopathy / Hematological Disorder | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Conduction Defects w/o Permanent Pacemaker | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Gastro-Intestinal Event | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Heart Failure | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
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| Infection / Inflammation | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
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| Metabolic Disorder | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
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| Neurological Event Minor - Not Stroke | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Orthopedic Event | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Other | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
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| Peripheral Edema | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Renal Insufficency not requiring Dialysis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
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| Respiratory Comp / Failure not requ. Resp Assistance | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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| Transitory Psychotic Syndrome | Psychiatric disorders | MedDRA (23.0) | 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 |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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