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

Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Sapien XT™ transcatheter heart valve and delivery system

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 Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst
• France
  • Massy, France, 91300
    • Institut Hospitalier Jacques Cartier
  • Paris, France, 75018
    • Hospital Bichat Claude Bernard
  • Rouen, France, 76000
    • CHU Hospital Charles Nicolle
  • Toulouse, France, 31076
    • Clinique Pasteur
• Germany
  • Hamburg, Germany, 22527
    • Hamburg University Cardiovascular Center
  • Karlsruhe, Germany, 76185
    • City Clinics Karlsruhe
  • Leipzig, Germany, 04829
    • Heart Center Leipzig
  • Munich, Germany, 80804
    • Schwabing Clinic
• United Kingdom
  • London, United Kingdom, SE1 7EH
    • St. Thomas' Hospital - NHS Trust
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital - NHS Trust

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Deaths	Number of death at 30-days from the index procedure.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Stroke	Total number of participates with a stroke.	30 days from the index procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 8, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (Estimate): January 12, 2009

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Aortic Stenosis; Transfemoral; Transcatheter; Valvular Heart Disease; Heart Valve Therapy; Sapien Valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2008-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No