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

NCT01419015 | Completed Results DMC FDA Device

• 1 other identifier: EW-P-002
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Aortic Valve Stenosis

Keywords

SAPIEN XT Valve (20mm); Cardiovascular Disease; Valvular Heart Disease; Aortic Stenosis; Heart Valve Therapy; Transcatheter; Transfemoral; Efficacy endpoints; Indexed Aortic Valve Area; NYHA

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TAVI-TF Approach

EXPERIMENTAL

Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.

Device: SAPIEN XT NovaFlex delivery system

Interventions

SAPIEN XT NovaFlex delivery system DEVICE

Transcatheter aortic valve implantation via transfemoral approach.

Also known as: SAPIEN XT, NovaFlex delivery system

TAVI-TF Approach

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were judged difficult to safely undergo AVR
• Severe senile degenerative aortic valve stenosis
• NYHA Functional Class II or greater
• Signed Informed Consent

You may not qualify if:

• Aortic valve is congenital unicuspid or bicuspid
• Annulus size between \< 16 mm or \> 19 mm
• LVEF \< 20 %

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (4)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Sakakibara Heart Institute

Fuchū, Toyko, 183-003, Japan

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Aya Saeki
• Organization: Edwards Lifesciences

Aya_Saeki@edwards.com

Study Officials

• Morimasa Takayama, MD

  Sakakibara Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2017
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-07

Locations

JP (4)