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A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic Stenosis
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic Stenosis
 
Region Sponsors
California - Northern
Edwards Lifesciences
 
Acronym KP IRB No.
CN-16-2597-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Aortic Stenosis
 
Purpose
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).
 
Detailed Description
Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 2% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Symptomatic, severe, calcific aortic stenosis with the following TTE criteria: Jet velocity >= 4.0 m/s or mean gradient >= 40 mmHg AND AVA <= 1.0 cm2 or AVA index <= 0.6 cm2/m2
  • Aortic valve annulus 273 mm2 - 683 mm2 measured by 3D imaging (CT, TEE or MRI)
  • Adequate iliofemoral access with minimum average vessel diameter of 5.5mm (20, 23, 26mm) and 6.0mm (29mm) and acceptable level of vessel calcification and tortuosity for safe device implant
  • NYHA Functional Class >= II
  • Heart team agrees the patient has a risk of operative mortality < 2% (e.g., STS <4)
  • The study patient 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 (IRB) of the respective clinical site
 
Exclusion Criteria
  • >= 1/4 frailty. (Only 0/4 frail patients may be enrolled in the trial)
  • Evidence of an acute myocardial infarction <= 1 month (30 days) before randomization with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Any one of the following criteria meets the diagnosis for MI: Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin (cTn)) with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischemia, New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB). Development of pathological Q waves in the ECG Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, Identification of an intracoronary thrombus by angiography
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  • Severe aortic regurgitation (>3+)
  • Severe mitral regurgitation (>3+)
  • Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion)
  • Any patient with a balloon valvuloplasty (BAV) within 30 days of the valve implant procedure (unless BAV is a bridge to procedure after a qualifying ECHO)
  • Contact Study Coordinator for full list of exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Aortic Valve Stenosis
  • Heart Valve Diseases
  • Cardiovascular Diseases
  • Pathological Conditions, Anatomical
  • Constriction, Pathologic
  • Ventricular Outflow Obstruction
  • Heart Diseases
  • Cardiology
 
KP Clinical Facility
  • San Francisco Medical Center
 
Clinical Area
  • Cardiology


Principal Investigator:
Edward McNulty, MD
Contact Information:
- Catherine Vowles, RN
-catherine.vowles@kp.org
-San Francisco Medical Center


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