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A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.
Purpose: To evaluate the safety and efficacy of THV-9300 for patients who have severe symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet and for whom undergoing a surgery safely would be difficult.
Follow-up: 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 months and annually for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI - TF and TA approach | Experimental | Transcatheter aortic valve implantation and transfemoral/ transapical approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve implantation | Device | Transcatheter aortic valve implantation via transapical and transfemoral approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the AVA and NYHA Functional Classification | Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 6 months after the procedure. 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. The AVA at 6 months > 1.0 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death Adverse Event Rate | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshiki Sawa, MD, PhD | Osaka University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurashiki Central Hospital | Kurashiki | Okayama-ken | 710-8602 | Japan | ||
| Osaka University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28321002 | Derived | Sawa Y, Takayama M, Goto T, Takanashi S, Komiya T, Tobaru T, Maeda K, Kuratani T, Sakata Y; PREVAIL JAPAN Investigators. Five-Year Outcomes of the First Pivotal Clinical Trial of Balloon-Expandable Transcatheter Aortic Valve Replacement in Japan (PREVAIL JAPAN). Circ J. 2017 Jul 25;81(8):1102-1107. doi: 10.1253/circj.CJ-17-0111. Epub 2017 Mar 17. | |
| 24927855 |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAVI - TF Approach | Transcatheter aortic valve implantation and transfemoral approach Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical and transfemoral approach |
| FG001 | TAVI-TA Approach | Transcatheter aortic valve implantation - Transapical approach |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAVI - TF Approach | Transcatheter aortic valve implantation and transfemoral approach Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach |
| BG001 | TAVI-TA Approach |
| 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 | Improvement of the AVA and NYHA Functional Classification | Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 6 months after the procedure. 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. The AVA at 6 months > 1.0 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. | Posted | Number | % of participants | 6 Months |
|
6 Months
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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 | TAVI - TF Approach | Transcatheter aortic valve implantation and transfemoral approach Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute adrenocortical insufficiency | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shin Sakai, PhD | Edwards Lifesciences | shin_sakai@edwards.com |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D002318 | Cardiovascular Diseases |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Suita |
| Osaka |
| 565-0871 |
| Japan |
| Sakakibara Heart Institute | Chōshi | Tokyo | 183-0003 | Japan |
| Watanabe Y, Hayashida K, Takayama M, Mitsudo K, Nanto S, Takanashi S, Komiya T, Kuratani T, Tobaru T, Goto T, Lefevre T, Sawa Y, Morice MC. First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial. J Cardiol. 2015 Feb;65(2):112-6. doi: 10.1016/j.jjcc.2014.05.001. Epub 2014 Jun 11. |
| 24595532 | Derived | Sawa Y, Takayama M, Mitsudo K, Nanto S, Takanashi S, Komiya T, Kuratani T, Tobaru T, Goto T. Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial. Surg Today. 2015 Jan;45(1):34-43. doi: 10.1007/s00595-014-0855-y. Epub 2014 Mar 5. |
Transcatheter aortic valve implantation - Transapical approach Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| NYHA III/IV | Measure Description: 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. | Number | % of participants |
|
| NYHA II | Measure Description: 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. | Number | % of Patients |
|
| Arrhythmia | Number | % of patricipants |
|
| Porcelain Aorta | Number | % of Participants |
|
| Renal Disease | Number | % of Participants |
|
| OG001 | TAVI-TA Approach | Transcatheter aortic valve implantation - Transapical approach Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach |
|
|
| Secondary | Death | Death Adverse Event Rate | Posted | Number | percentage of participants | 6 months |
|
|
|
| 2 |
| 37 |
| 25 |
| 37 |
| 19 |
| 37 |
| EG001 | TAVI-TA Approach | Transcatheter aortic valve implantation - Transapical approach Transcatheter aortic valve implantation: Transcatheter aortic valve implantation via transapical or transfemoral approach | 5 | 27 | 27 | 27 | 13 | 27 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Aortic Valve Replacement | Surgical and medical procedures | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Complete atrioventricular block | Cardiac disorders | Systematic Assessment |
|
| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
|
| Cardiopulmonary arrest | Cardiac disorders | Systematic Assessment |
|
| Cerebral infarction | Vascular disorders | Systematic Assessment |
|
| Suppurative cholangitis | Infections and infestations | Systematic Assessment |
|
| Coronary occlusion | Cardiac disorders | Systematic Assessment |
|
| Coronary stenosis | Cardiac disorders | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hepatic dysfunction | Hepatobiliary disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Mastitis | Infections and infestations | Systematic Assessment |
|
| Peripheral edema | General disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | Systematic Assessment |
|
| Hemorrhoid bleeding | Vascular disorders | Systematic Assessment |
|
| Bleeding | Vascular disorders | Systematic Assessment |
|
| Aortic rupture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Obstructive airway disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Renal dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Disuse syndrome | General disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Rotatory vertigo | Nervous system disorders | Systematic Assessment |
|
| Study valve dislodge from aortic annulus | Surgical and medical procedures | Systematic Assessment |
|
| Balloon contractile dysfunction | Surgical and medical procedures | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | Systematic Assessment |
|
| Vocal cord polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | Systematic Assessment |
|
| Aortic regurgitation | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
|
| Complete atrioventricular block | Cardiac disorders | Systematic Assessment |
|
| Left bundle branch block | Cardiac disorders | Systematic Assessment |
|
| Right bundle branch block | Cardiac disorders | Systematic Assessment |
|
| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Pulmonary congestion | Cardiac disorders | Systematic Assessment |
|
| Tricuspid regurgitation | Cardiac disorders | Systematic Assessment |
|
| Ventricular premature complex | Cardiac disorders | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Cerebellar infarction | Vascular disorders | Systematic Assessment |
|
| Cerebral infarction | Vascular disorders | Systematic Assessment |
|
| Intraoperative bleeding | Vascular disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatic dysfunction | Hepatobiliary disorders | Systematic Assessment |
|
| Contusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | Systematic Assessment |
|
| Renal dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Peripheral edema | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| General health decline | General disorders | Systematic Assessment |
|
| Elevation of CPK in blood | Investigations | Systematic Assessment |
|
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| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |