Edwards 12F Sheath Feasibility Study
- Conditions
- Aortic stenosisCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12624000100594
- Lead Sponsor
- Edwards Lifesciences LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1.Severe, calcific AS
2.Native aortic annulus size suitable for SAPIEN X4 THV
3.NYHA functional class greater than or equal to II
4.The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
1.Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
2.Aortic valve is unicuspid, non-calcified, or aortic valve is bicuspid with aneurysmal ascending aorta greater than 4.5 cm and/or severe raphe/leaflet calcification
3.Pre-existing mechanical or bioprosthetic valve in any position
4.Severe aortic regurgitation (greater than 3plus)
5.Severe mitral regurgitation (greater than 3olus) or greater than or equal to moderate mitral stenosis
6.Need for mitral, tricuspid, or pulmonic valve intervention within the next 12 months
7.Left ventricular ejection fraction less than 20%
8.Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
9.Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak (PVL) after THV implantation
10.Increased risk of coronary artery obstruction after THV implantation
11.Myocardial infarction within 30 days prior to the study procedure
12.Hypertrophic cardiomyopathy with subvalvular obstruction
13.Subjects with planned concomitant ablation for atrial fibrillation
14.Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
15.Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
16.Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
17.Endocarditis within 180 days prior to the study procedure
18.Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
19.Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
20.Renal insufficiency and/or renal replacement therapy
21.Leukopenia, anaemia, thrombocytopenia
22.Inability to tolerate or condition precluding treatment with antithrombotic therapy
23.Hypercoagulable state or other condition that increases risk of thrombosis
24.Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
25.Subject refuses blood products
26.BMI greater than 50 kg/m2
27.Estimated life expectancy less than 24 months
28.Female who is pregnant or lactating
29.Active SARS-CoV-2 infection
30.Participating in another investigational drug or device study that has not reached its primary endpoint
31.Subject considered to be part of a vulnerable population
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vascular and access-related complications (assessed by review of medical records and using VARC-3 definitions), e.g., haematoma, embolization, nerve injury .[ 30 days]
- Secondary Outcome Measures
Name Time Method This is a composite secondary outcome. Successful access, delivery of the device, and retrieval of the delivery system (assessed by review of medical records).[ End of the procedure.]