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
Sponsor Edwards Lifesciences
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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

improvement in Aortic valve area (AVA) and NYHA functional classification
time frame: 6 Months

Secondary Outcomes

Adverse Event Rate
time frame: 5 Years

Eligibility Criteria

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 %

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.