PREVAIL EU: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00820599
First received: January 8, 2009
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"), its 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
Aortic Valve Stenosis
Device: Sapien XT™ transcatheter heart valve and its transfemoral delivery system

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PREVAIL EU Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Primary Endpoint: Freedom from death at 30 days from the index procedure [ Time Frame: 30 days from the index procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Freedom from vascular complications, stroke, myocardial infarction, reintervention, valve embolization, conduction defects requiring permanent pacemaker, aortic regurgitation, perivalvular leak [ Time Frame: 30 days from the index procedure ] [ Designated as safety issue: Yes ]

Enrollment: 213
Study Start Date: December 2008
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Sapien XT™ transcatheter heart valve and its transfemoral delivery system

    Transfemoral placement of a transcatheter aortic heart valve

    SAPIEN XT™ study valve and its transfemoral delivery components

Detailed Description:

Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007. This trial is designed to evaluate the 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 its delivery components.

Enrollment: In total, a minimum of 150 patients will be enrolled to receive the study valve under this protocol.

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.

Clinical Sites: Up to 11 sites in Europe

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All candidates for this study must meet all of the following inclusion criteria:

  1. 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:

    1. Porcelain aorta or other preconditions which precludes cannulation for cardiopulmonary bypass, cross-clamp application or surgical access to the mediastinum.
    2. Radiation treatment of the sternum that precludes an open chest procedure
    3. Chest deformities or remote mediastinitis that preclude an open chest procedure
    4. Other high risk conditions such as:

    i. prior thoracic or CABG surgery, ii. chronic pulmonary dysfunction - (FEV1 < 70)

  2. Patient has severe senile degenerative aortic valve stenosis with a documented initial aortic valve area (AVA) of <1.0 cm2 (indexed EOA <0.6 cm2/m2), mean gradient >40 mmHg and/or jet velocity greater than 4.0 m/s. [4] (AHA 2006) (AVA baseline measurement must be within 30 days of study valve implantation procedure).
  3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  4. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site.
  5. Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
  6. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

  1. Evidence of an acute myocardial infarction <1month before the intended index procedure (defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB > twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition).
  2. Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  4. Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).
  5. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
  6. Presence of a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
  7. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb< 9 mg%), thrombocytopenia (platelet count <50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
  8. Untreated clinically significant coronary artery disease requiring revascularization.
  9. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
  10. Need for emergency intervention for any reason.
  11. Hypertrophic obstructive cardiomyopathy with or without obstruction (HOCM).
  12. Severe ventricular dysfunction with LVEF <20%.
  13. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  14. Active infection or endocarditis.
  15. Active peptic ulcer or upper GI bleeding within the prior 3 months.
  16. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix/Iscover), or sensitivity to contrast media, which cannot be adequately pre-medicated.
  17. Native aortic annulus size < 18 mm or > 21mm (23mm study valve) or < 22mm or > 25mm (26mm study valve) per the baseline echocardiogram as estimated by the left ventricular outflow tract (LVOT). Valve used (23 mm or 26 mm Edwards SAPIEN THV) to be at the discretion of the implanting physician.
  18. Recent cerebrovascular accident (CVA) or neurological dysfunction (TIA) (within past 6 weeks, patients with severe senile dementia).
  19. Severe renal insufficiency (creatinine >3.0 mg/dl or 265 µmol/L) and/or end stage renal disease requiring chronic dialysis.
  20. Life expectancy < 12 months due to non-cardiac co-morbid conditions.
  21. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend or aortic arch >200°), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only).
  22. Ileo-femoral vessel characteristics that would preclude safe placement of introducer sheaths such as severe obstructive calcification (including circumferential calcification), severe tortuosity (>two 90 degree bends especially where there is moderate or severe calcification), or vessels size less than 6 mm.
  23. Currently participating in an investigational drug or another device study. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials].
  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: NCT00820599

Locations
Belgium
Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst
Aalst, Belgium, 9300
France
Institut Hospitalier Jacques Cartier
Massy, France, 91300
Hospital Bichat Claude Bernard
Paris, France, 75018
CHU Hospital Charles Nicolle
Rouen, France, 76000
Clinique Pasteur
Toolouse, France, 31076
Germany
Hamburg University Cardiovascular Center
Hamburg, Germany, 22527
City Clinics Karlsruhe
Karlsruhe, Germany, 76185
Heart Center Leipzig
Leipzig, Germany, 04829
Schwabing Clinic
Munich, Germany, 80804
United Kingdom
St. Thomas' Hospital - NHS Trust
London, United Kingdom, SE1 7EH
Kings College Hospital - NHS Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Study Director: Prof. Dr. Stefan Sack Cardiology Clinic of Schwabing Clinic
Study Director: Ihsen Merioua, Dr. Edwards Lifesciences SA
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00820599     History of Changes
Other Study ID Numbers: 2008-04
Study First Received: January 8, 2009
Last Updated: April 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Edwards Lifesciences:
Sapien Valve
Cardiovascular Diseases
Valvular Heart Disease
Aortic Stenosis
Heart Valve Therapy
Transfemoral
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 July 20, 2014