Status:
COMPLETED
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replace...
Eligibility Criteria
Inclusion
- Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
- Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2
- Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
- New York Heart Association functional class ≥ II
- Judged by the Heart Team to be at intermediate risk for open surgical therapy
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion
- Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position.
- Severe aortic regurgitation (\> 3+)
- Severe mitral regurgitation (\> 3+) or ≥ moderate stenosis
- Ventricular dysfunction with left ventricular ejection fraction \< 30%
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
- Subjects with planned concomitant ablation for atrial fibrillation
- Hypertrophic cardiomyopathy with obstruction
- Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
- Complex coronary artery disease:
- Unprotected left main coronary artery
- SYNTAX score \> 32
- Heart Team assessment that optimal revascularization cannot be performed
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath
- Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
- Active bacterial endocarditis within 180 days of the valve implant procedure
- Stroke or transient ischemic attack within 90 days of the valve implant procedure
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
- Severe lung disease (Forced Ejection Volume 1 \< 50% predicted) or currently on home oxygen
- Severe pulmonary hypertension
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
- History of cirrhosis or any active liver disease
- Renal insufficiency and/or renal replacement therapy at the time of screening
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Significant frailty as determined by the Heart Team
- Subject refuses blood products
- Body mass index \> 50 kg/m2
- Estimated life expectancy \< 24 months
- Positive urine or serum pregnancy test in female subjects of childbearing potential
- Currently participating in an investigational drug or another device study.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03471065
Start Date
June 1 2018
End Date
January 21 2025
Last Update
May 18 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Paul's Hospital
Vancouver, British Columbia, Canada
2
Hamilton Health Sciences
Hamilton, Ontario, Canada
3
Toronto General Hospital
Toronto, Ontario, Canada
4
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada