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Active Clinical Trials

CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement (ExCEED)

Active NCT:
03517436
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Edwards Lifesciences
Contact: 

For more information, please contact Brooke Thomas at 412-359-6908 or Brooke.Thomas@ahn.org.

A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in IntermEDiate Risk Patients who have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement (ExCEED)

Purpose: 

To establish the safety and effectiveness of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR)

Ages Eligible for Study:  19 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  1. Severe, calcific AS meeting the following transthoracic echocardiogram (TTE) criteria: AV area ≤ 1.0 cm2 OR AV area index ≤ 0.6 cm2/m2, Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
  2. NYHA functional class ≥ II
  3. Judged by the Heart Team to be at intermediate risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% and < 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator)
  4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

  1. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion).
  2. Known hypersensitivity to Nitinol (nickel or titanium)
  3. Severe aortic regurgitation (> 3+)
  4. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
  5. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
  6. Stroke or transient ischemic attack within 90 days of the valve implant procedure
  7. Severe lung disease or currently on home oxygen
  8. Severe pulmonary hypertension
  9. History of cirrhosis or any active liver disease