Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (JAPAN)
This trial is active, not recruiting.
|Conditions||aortic valve stenosis, efficacy endpoints improvement of aortic valve area and nyha functional classification|
|Treatment||transcatheter aortic valve implantation|
|Start date||April 2010|
|End date||October 2011|
|Trial size||69 participants|
|Trial identifier||NCT01113983, EW-P-001|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
improvement in Aortic valve area (AVA) and NYHA functional classification
time frame: 6 Months
Adverse Event Rate
time frame: 5 Years
Male or female participants of any age.
Inclusion Criteria: - Primary: Patients who were judged difficult to safely undergo AVR Severe senile degenerative aortic valve stenosis NYHA Functional Class II or greater Signed Informed Consent Exclusion Criteria: - Primary: Aortic valve is congenital unicuspid or bicuspid Annulus size between < 18 mm or > 25 mm LVEF < 20 %
|Official title||A Clinical Trial of a Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis|
|Description||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. Enrollment: 69 patients Transfemoral approach: 42 patients (No. of patients needed: 23) Transapical approach: 27 patients (No. of patients needed: 19) 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: Osaka University Hospital Kurashiki Central Hospital Sakakibara Heart Institute|
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