NCT01419015

PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial

A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	SAPIEN XT NovaFlex delivery system	Transcatheter aortic valve implantation via transfemoral approach.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-01
• Completion: 2017-12-01
• First posted: 2011-08-17
• Last updated: 2020-08-06
• Results posted: 2020-08-06

Locations

4 sites across 1 country: Japan

Regulatory

• FDA-regulated device study