PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT00820599
• Lead Sponsor: Edwards Lifesciences

Brief Summary

A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

Detailed Description

Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007.

Clinical Sites: Up to 11 sites in Europe

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2010-12
• Study Completion: 2016-03
• Results First Submitted: 2020-09-27
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Results First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

All candidates for this study must meet all of the following inclusion criteria:

1. Patients must have co-morbidities such that the surgeon (Co Investigator) and interventional cardiologist (Principal Investigator) concur that the predicted risk of operative mortality is > 15% with a minimum STS Risk Calculator score of ≥ 10 and/or Logistic EuroSCORE of > 20%.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site.
4. Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria

1. Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
2. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
3. Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Deaths	30 days	Number of death at 30-days from the index procedure.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Stroke	30 days from the index procedure	Total number of participates with a stroke.

Trial Locations

Locations (11)

Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst; 🇧🇪 Aalst, Belgium

Institut Hospitalier Jacques Cartier; 🇫🇷 Massy, France

Hospital Bichat Claude Bernard; 🇫🇷 Paris, France

CHU Hospital Charles Nicolle; 🇫🇷 Rouen, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Hamburg University Cardiovascular Center; 🇩🇪 Hamburg, Germany

City Clinics Karlsruhe; 🇩🇪 Karlsruhe, Germany

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

Schwabing Clinic; 🇩🇪 Munich, Germany

St. Thomas' Hospital - NHS Trust; 🇬🇧 London, United Kingdom

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