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

• ClinicalTrials.gov Identifier: NCT00820599
• Recruitment Status: Completed
• First Posted: January 12, 2009
• Last Update Posted: February 10, 2017
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aortic Valve Stenosis	Device: Sapien XT™ transcatheter heart valve and delivery system	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 213 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)
• Actual Study Start Date: December 2008
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: TAVR; Transaortic Valve Replacement	Device: Sapien XT™ transcatheter heart valve and delivery system

Outcome Measures

Primary Outcome Measures :

1. Primary Endpoint: Freedom from death at 30 days from the index procedure [ Time Frame: 30 days from the index procedure ]

Secondary Outcome Measures :

1. Freedom from vascular complications, stroke, myocardial infarction, reintervention, valve embolization, conduction defects requiring permanent pacemaker, aortic regurgitation, perivalvular leak [ Time Frame: 30 days from the index procedure ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

Belgium

Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst

Aalst, Belgium, 9300

France

Institut Hospitalier Jacques Cartier

Massy, France, 91300

Hospital Bichat Claude Bernard

Paris, France, 75018

CHU Hospital Charles Nicolle

Rouen, France, 76000

Clinique Pasteur

Toolouse, France, 31076

Germany

Hamburg University Cardiovascular Center

Hamburg, Germany, 22527

City Clinics Karlsruhe

Karlsruhe, Germany, 76185

Heart Center Leipzig

Leipzig, Germany, 04829

Schwabing Clinic

Munich, Germany, 80804

United Kingdom

St. Thomas' Hospital - NHS Trust

London, United Kingdom, SE1 7EH

Kings College Hospital - NHS Trust

London, United Kingdom, SE5 9RS

Sponsors and Collaborators

Edwards Lifesciences

Investigators

• Study Director: Prof. Dr. Stefan Sack; Cardiology Clinic of Schwabing Clinic
• Study Director: Isabelle Fourthin; Edwards Lifesciences SA

More Information

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT00820599
• Other Study ID Numbers: 2008-04
• First Posted: January 12, 2009
• Last Update Posted: February 10, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Edwards Lifesciences:

Sapien Valve; Cardiovascular Diseases; Valvular Heart Disease; Aortic Stenosis; Heart Valve Therapy; Transfemoral; Transcatheter

Additional relevant MeSH terms:

Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction