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A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral 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 (20mm) 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.
Enrollment: 15 patients (No.of patients needed: 12)
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.
Clinical sites:
1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4) Kokura Memorial Hospital
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI-TF Approach | Experimental | Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAPIEN XT NovaFlex delivery system | Device | Transcatheter aortic valve implantation via transfemoral approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NYHA Improvement and AVA >= 0.65 cm2 | Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 1 year 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 1 year >= 0.65 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. Note: One patient did not complete a 6-month echo. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morimasa Takayama, MD | Sakakibara Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8555 | Japan | ||
| Kurashiki Central Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 20-mm TF-TAVR | Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 20-mm TF-TAVR | Patients with symptomatic severe aortic stenosis received a 20 mm SAPIEN XT valve through the transfemoral procedure. |
| 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 | NYHA Improvement and AVA >= 0.65 cm2 | Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 1 year 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 1 year >= 0.65 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. Note: One patient did not complete a 6-month echo. | Posted | Count of Participants | Participants | 1 year |
|
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. SAPIEN XT NovaFlex delivery system will be used. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aya Saeki | Edwards Lifesciences | Aya_Saeki@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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| Kurashiki |
| Okayama-ken |
| 710-8602 |
| Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Sakakibara Heart Institute | Fuchū | Toyko | 183-003 | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| NYHA Class III/IV | Count of Participants | Participants |
|
| Porcelain Aorta | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Arrhythmia | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 2 |
| 17 |
| 8 |
| 17 |
| 11 |
| 17 |
| Acute myocardial Infraction | Cardiac disorders | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
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| Device malposition | General disorders | Systematic Assessment |
|
| Aortic injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Femoral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cardiac perforation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spinal Compression Fracture | Nervous system disorders | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | Systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
|
| Cerebral Infraction | Nervous system disorders | Systematic Assessment |
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| Dementia | Nervous system disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Aortic regurgitation | Cardiac disorders | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Gingival bleeding | Vascular disorders | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lower gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Subcutaneous hemorrhage | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Increased Intraocular pressure | Investigations | Systematic Assessment |
|
| Cataract surgery | Surgical and medical procedures | Systematic Assessment |
|
| Epidermal necrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Left Leg Block | General disorders | Systematic Assessment |
|
| Ventricular Extrasystole | Cardiac disorders | Systematic Assessment |
|
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