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Trial record 2 of 7 for:    Prevail AND delivery system

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820599
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE January 8, 2009
First Posted Date  ICMJE January 12, 2009
Last Update Posted Date February 10, 2017
Actual Study Start Date  ICMJE December 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
Primary Endpoint: Freedom from death at 30 days from the index procedure [ Time Frame: 30 days from the index procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Official Title  ICMJE Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE Device: Sapien XT™ transcatheter heart valve and delivery system
Study Arms  ICMJE Experimental: TAVR
Transaortic Valve Replacement
Intervention: Device: Sapien XT™ transcatheter heart valve and delivery system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2011)
213
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
150
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00820599
Other Study ID Numbers  ICMJE 2008-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Prof. Dr. Stefan Sack Cardiology Clinic of Schwabing Clinic
Study Director: Isabelle Fourthin Edwards Lifesciences SA
PRS Account Edwards Lifesciences
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP