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: January 30, 2013
Last verified: January 2013

January 26, 2010
January 30, 2013
September 2009
February 2011   (final data collection date for primary outcome measure)
Freedom from death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01238835 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prevail TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical)
Prevail TA Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Valve Stenosis
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
Experimental: Transapical
Intervention: Device: SAPIEN XT™ Transapical aortic valve replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
218
February 2016
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   United Kingdom
 
NCT01238835
2009-06
Yes
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Prof. Dr. Thomas Walther Kerckhoff-Klinik Bad Nauheim
Principal Investigator: Dr. Olaf Wendler King's College London
Edwards Lifesciences
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP