PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
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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
Results First Posted : November 2, 2020
Last Update Posted : November 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aortic Valve Stenosis | Device: Sapien XT™ transcatheter heart valve and delivery system | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 214 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 |

Arm | Intervention/treatment |
---|---|
Experimental: TAVR
Transaortic Valve Replacement
|
Device: Sapien XT™ transcatheter heart valve and delivery system |
- Number of Deaths [ Time Frame: 30 days ]Number of death at 30-days from the index procedure.
- Number of Participants With a Stroke [ Time Frame: 30 days from the index procedure ]Total number of participates with a stroke.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All candidates for this study must meet all of the following inclusion criteria:
- 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%.
- Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- 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.
- Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion Criteria:
- Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820599
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 | |
Toulouse, 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 |
Study Director: | Prof. Dr. Stefan Sack | Cardiology Clinic of Schwabing Clinic | |
Study Director: | Isabelle Fourthin | Edwards Lifesciences SA |
Responsible Party: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT00820599 |
Other Study ID Numbers: |
2008-04 |
First Posted: | January 12, 2009 Key Record Dates |
Results First Posted: | November 2, 2020 |
Last Update Posted: | November 2, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sapien Valve Cardiovascular Diseases Valvular Heart Disease Aortic Stenosis |
Heart Valve Therapy Transfemoral Transcatheter |
Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |