This trial is active, not recruiting.

Condition aortic valve stenosis
Treatment sapien xt novaflex delivery system
Sponsor Edwards Lifesciences
Start date June 2011
End date January 2013
Trial size 15 participants
Trial identifier NCT01419015, EW-P-002


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.
sapien xt novaflex delivery system SAPIEN XT
Transcatheter aortic valve implantation via transfemoral approach.

Primary Outcomes

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

Secondary Outcomes

Adverse Event Rate
time frame: 5 Years

Eligibility Criteria

All participants at least 19 years old.

Inclusion Criteria: - 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: - Aortic valve is congenital unicuspid or bicuspid - Annulus size between < 16 mm or > 19 mm - LVEF < 20 %

Additional Information

Official title A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis
Principal investigator Morimasa Takayama, MD
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.