Prevail TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) (PrevailTA)
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| First Received Date ICMJE | January 26, 2010 | ||||||||
| Last Updated Date | January 30, 2013 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Freedom from death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01238835 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevail TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) | ||||||||
| Official Title ICMJE | Prevail TA Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical) | ||||||||
| Brief Summary | A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical 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. |
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| Detailed Description | Edwards Lifesciences obtained CE marking authorization for transapical delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the first generation Ascendra™ delivery system in 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) the same year. 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 next generation Ascendra™ delivery components. Enrollment: In total, a minimum of 150 patients will be enrolled to receive the study valve under this protocol. An application for CE marking authorization will be submitted to the EC Notified Body during the course of the trial. 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, 30 days, 6 month annually for 5 years. Clinical Sites: Approximately 10 sites in Europe PREVAIL TA Continued Access: After inclusion of 150 patients, continued access will be provided to patients requiring a 29 mm valve until receipt of CE-mark. Approximately 50 patients are expected to be enrolled in the continued access and it will be conducted under the same protocol with the same inclusion/exclusion criteria and primary and secondary endpoints. Up to 10 additional sites will be added. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Aortic Valve Stenosis | ||||||||
| Intervention ICMJE | Device: SAPIEN XT™ Transapical aortic valve replacement
Transcatheter aortic valve implantation via the transapical approach
Other Names:
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| Study Arm (s) | Experimental: Transapical
Intervention: Device: SAPIEN XT™ Transapical aortic valve replacement |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 218 | ||||||||
| Estimated Completion Date | February 2016 | ||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Austria, France, Germany, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01238835 | ||||||||
| Other Study ID Numbers ICMJE | 2009-06 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Edwards Lifesciences | ||||||||
| Study Sponsor ICMJE | Edwards Lifesciences | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Edwards Lifesciences | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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