Prevail TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) (PrevailTA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aortic Valve Stenosis |
Device: SAPIEN XT™ Transapical aortic valve replacement |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prevail TA Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical) |
- Freedom from death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Freedom from:
- stroke
- myocardial infarction
- valve/device related reintervention/reoperation
- access related complications
- valve embolization
- conduction defects requiring permanent pacemaker
- Efficacy parameters [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- NYHA
- 6 Minute Walk Test
- Echocardiographic variables like effective orifice area, peak and mean gradient, aortic insufficiency and perivalvular leak
| Enrollment: | 218 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | February 2016 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Transapical |
Device: SAPIEN XT™ Transapical aortic valve replacement
Transcatheter aortic valve implantation via the transapical approach
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
- EuroSCORE of ≥ 15 %
- severe senile degenerative aortic valve stenosis …
- symptomatic aortic valve stenosis…
- Informed consent
- Compliance
Exclusion:
- Logistic Euroscore > 40 %
- Evidence of an acute myocardial infarction ..
- congenital unicuspid or congenital bicuspid valve/ non-calcified.
- Mixed aortic valve disease ..
- annulus size < 18 mm or > 27mm
- Pre-existing prosthetic heart valve in any position
- Any therapeutic invasive cardiac procedure..
- Severe ventricular dysfunction
- Gorlin Conundrum (AV low flow, low gradient)
- Untreated clinically significant coronary artery disease requiring revascularization.
- Echocardiographic evidence of intracardiac mass, thrombus/ vegetation /presence /left ventricular aneurysm
- Blood dyscrasias..
- Hemodynamic instability ..
- Emergency intervention
- Hypertrophic obstructive cardiomyopathy
- Active infection / endocarditis.
- Active peptic ulcer or upper GI bleeding…
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix/Iscover), or sensitivity to contrast media, which cannot be adequately premedicated.
- Recent CVA or TIA ..
- Severe renal insufficiency
- Life expectancy < 12 months due to non-cardiac comorbid conditions.
- Pregnant or lactating woman
- Currently participating in an investigational drug or another device study
Contacts and Locations| Austria | |
| Medizinische Universitat Wien Univ.Klinik f.Chirurgie | |
| Wien, Austria, 1019 | |
| France | |
| Hôspital Bichat | |
| Paris, France, 75018 | |
| Germany | |
| Herz-Und Gefasszentrum Bad Bevensen | |
| Bad Bevensen, Germany, 29549 | |
| Kerckhoff-Klinik | |
| Bad Nauheim, Germany, 61231 | |
| Herz-und-Gefass Klinik | |
| Bad Neustadt, Germany, 97616 | |
| Herz-und Diabeteszentrum NRW | |
| Bad Oeynhausen, Germany, 32545 | |
| Schüchtermann-Klinik | |
| Bad Rothenfelde, Germany, 49214 | |
| Heart Center University Cologne | |
| Cologne, Germany, 50924 | |
| Herzzentrum Dresden GmbH | |
| Dresden, Germany, 01307 | |
| University Clinic Erlangen | |
| Erlangen, Germany, 91054 | |
| University Hospital Essen, West German Heart Center | |
| Essen, Germany, 45122 | |
| Universitätsklinikum Hamburg-Eppendorf | |
| Hamburg, Germany, 20246 | |
| Cardiac Surgery Karlsruhe | |
| Karlsruhe, Germany, 76185 | |
| Heart Center Leipzig | |
| Leipzig, Germany, 04829 | |
| University Hospital Munich-Grosshadern | |
| Munich, Germany, 81377 | |
| Hospital Munich-Bogenhausen | |
| Munich, Germany, 81925 | |
| German Heart Center Munich | |
| Munich, Germany, 80636 | |
| Robert-Bosch-Krankenhaus | |
| Stuttgart, Germany, 70376 | |
| United Kingdom | |
| St. Thomas' Hospital - NHS Trust | |
| London, United Kingdom, SE1 7EH | |
| King's College Hospital | |
| London, United Kingdom, SE5 9RS | |
| Principal Investigator: | Prof. Dr. Thomas Walther | Kerckhoff-Klinik Bad Nauheim |
| Principal Investigator: | Dr. Olaf Wendler | King's College London |
More Information
No publications provided
| Responsible Party: | Edwards Lifesciences |
| ClinicalTrials.gov Identifier: | NCT01238835 History of Changes |
| Other Study ID Numbers: | 2009-06 |
| Study First Received: | January 26, 2010 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Austria: Federal Office for Safety in Health Care France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Ministry of Health |
Keywords provided by Edwards Lifesciences:
|
Sapien XT Valve Valvular Heart Disease Aortic Stenosis |
Heart Valve Therapy Transapical Transcatheter |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Constriction, Pathologic Heart Valve Diseases Heart Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013