Prevail TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) (PrevailTA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01238835
First received: January 26, 2010
Last updated: April 23, 2014
Last verified: April 2014
  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)

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Freedom from death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • Sapien XT
  • Next generation Ascendra delivery system inclusive accessory

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
Criteria

Inclusion:

  1. EuroSCORE of ≥ 15 %
  2. severe senile degenerative aortic valve stenosis …
  3. symptomatic aortic valve stenosis…
  4. Informed consent
  5. Compliance

Exclusion:

  1. Logistic Euroscore > 40 %
  2. Evidence of an acute myocardial infarction ..
  3. congenital unicuspid or congenital bicuspid valve/ non-calcified.
  4. Mixed aortic valve disease ..
  5. annulus size < 18 mm or > 27mm
  6. Pre-existing prosthetic heart valve in any position
  7. Any therapeutic invasive cardiac procedure..
  8. Severe ventricular dysfunction
  9. Gorlin Conundrum (AV low flow, low gradient)
  10. Untreated clinically significant coronary artery disease requiring revascularization.
  11. Echocardiographic evidence of intracardiac mass, thrombus/ vegetation /presence /left ventricular aneurysm
  12. Blood dyscrasias..
  13. Hemodynamic instability ..
  14. Emergency intervention
  15. Hypertrophic obstructive cardiomyopathy
  16. Active infection / endocarditis.
  17. Active peptic ulcer or upper GI bleeding…
  18. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix/Iscover), or sensitivity to contrast media, which cannot be adequately premedicated.
  19. Recent CVA or TIA ..
  20. Severe renal insufficiency
  21. Life expectancy < 12 months due to non-cardiac comorbid conditions.
  22. Pregnant or lactating woman
  23. Currently participating in an investigational drug or another device study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238835

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
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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: April 23, 2014
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 August 18, 2014