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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00820599
First received: January 8, 2009
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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 Intervention
Aortic Valve Stenosis Device: Sapien XT™ transcatheter heart valve and delivery system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Primary Endpoint: Freedom from death at 30 days from the index procedure [ Time Frame: 30 days from the index procedure ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 213
Actual Study Start Date: December 2008
Study Completion Date: March 2016
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAVR
Transaortic Valve Replacement
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820599

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     History of Changes
Other Study ID Numbers: 2008-04
Study First Received: January 8, 2009
Last Updated: February 7, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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

ClinicalTrials.gov processed this record on June 27, 2017