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Sponsored by: |
Edwards Lifesciences |
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Information provided by: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT00820599 |
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), RetroFlex 3™ 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 |
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Aortic Valve Stenosis |
Device: Aortic Valve Replacement |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | PREVAIL EU Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE) |
Estimated Enrollment: | 150 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | February 2015 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Transfemoral placement of a transcatheter aortic heart valve
SAPIEN XT™ study valve and RetroFlex™ 3 delivery components
Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the first generation RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007. This trial incorporates iterated products for this procedure.
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and RetroFlex™ 3 delivery components.
Enrollment: In total, a minimum of 150 patients will be enrolled to receive the study valve under this protocol.
After a minimum of 30 patients have been implanted with the study valve and have completed 30 day follow up, an application for CE marking authorization will be submitted to the EC Notified Body.. Enrollment of the remaining patients will continue after the receipt of CE mark certification as part of a post market surveillance plan.
Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge and 30 days for the clinical trial evaluation. For the post market clinical follow-up (PMCF) phase, the intervals will be baseline/index procedure, discharge, 30 days, 6 months and annually thereafter for 5 years. Patients enrolled in the trial prior to the receipt of CE mark certification will also be followed for 6 months and annually for 5 years under the PMCF phase.
Clinical Sites: Up to 10 sites in Europe
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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% .
A candidate who does not meet one of the risk score minimums (STS Risk Score < 10 or a Logistic EuroSCORE < 20) can be included in the study if a peer review by at least two surgeon investigators concludes and documents that the patient's predicted risk of operative mortality is ≥ 15%. The surgeon's assessment of operative comorbidities not captured by the STS score must be documented in the study case report form as well as in the patient medical record. The following conditions with an operative mortality of ≥15% will be considered for inclusion into the trial:
i. prior thoracic or CABG surgery, ii. chronic pulmonary dysfunction - (FEV1 < 70)
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are present:
Contact: Jodi Akin | 949 250 2730 | jodi_akin@edwards.com |
Germany | |
Schwabing Clinic | Recruiting |
Munich, Germany, 80804 | |
Contact: Stefan Sack, Dr +49 89 3068 2525 stefan.sack@klinikum-muenchen.de | |
Principal Investigator: Stefan Sack, Dr | |
City Clinics Karlsruhe | Recruiting |
Karlsruhe, Germany, 76185 | |
Contact: Gerhard Schymik, Dr +49 721 974 2960 gerhard.schymik@klinikum-karlsruhe.de | |
Principal Investigator: Gerhard Schymik, Dr | |
Heart Center Leipzig | Not yet recruiting |
Leipzig, Germany, 04829 | |
Contact: Gerhard Schuler, Dr +49 341 865 1427 schug@medizin.uni-leipzig.de | |
Principal Investigator: Gerhard Schuler | |
Heart and Vessel Center Bad Bevensen | Not yet recruiting |
Bad Bevensen, Germany, 29549 | |
Contact: Gerhard Wimmer-Greinecker, Dr +49 58 21-82-1772 g.wimmer-greinecker@hgz-bb.de | |
Principal Investigator: Gerhard Wimmer-Greinecker, Dr | |
Hamburg University Cardiovascular Center | Not yet recruiting |
Hamburg, Germany, 22527 | |
Contact: Joachim Schofer, Dr +49 40/889 009-0 schofer@herz-hh.de | |
Principal Investigator: Joachim Schofer Schofer, Dr |
Study Director: | Prof. Dr. Stefan Sack | Cardiology Clinic of Schwabing Clinic |
Study Director: | Monica Meyer | Edwards Lifesciences |
Responsible Party: | Edwards Lifesciences LLC ( Jodi Akin, Vice President, Global Clinical Affairs ) |
Study ID Numbers: | 2008-04 |
Study First Received: | January 8, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820599 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Sapien Valve Cardiovascular Diseases Valvular Heart Disease Aortic Stenosis |
Heart Valve Therapy Transfemoral Transcatheter |
Heart Diseases Constriction, Pathologic Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction |