A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement
- Conditions
- severe symptomatic aortic stenosissevere heart valve disorder1004697310007593
- Registration Number
- NL-OMON54270
- Lead Sponsor
- Optimapharm Deutschland GmbH (formerly: SSS International Clinical Research GmbH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
1. Female patients with severe aortic stenosis as follows:
• High gradient severe AS (Class I Indication for AVR):
Jet velocity >= 4.0 m/s
or mean gradient >= 40 mmHg with AVA <= 1.0 cm2
or AVA index <= 0.6 cm2/m2
OR
• Low gradient severe AS (Class I/IIa indication of AVR):
Jet velocity < 4.0 m/s and mean gradient < 40 mmHg and AVA <= 1.0 cm2 and AVA
index <= 0.6 cm2/m2 with confirmation of severe AS by: mean gradient >=40 mmHg on
dobutamine stress echocardiography and/or aortic valve calcium score >= 1200 AU
on non-contrast CT.
2. Age >= 18 years (for LUMC: >= 70 years)
3. 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)/Ethics Committee (EC) of the respective
clinical site.
1. Patient is not a candidate for both surgical and transcatheter aortic valve
replacement.
2. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV
based on 3D imaging analysis
3. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath.
4. Evidence of an acute myocardial infarction <= 1 month (30 days) before
randomization
5. Aortic valve is unicuspid, bicuspid, or is non-calcified
6. Severe aortic regurgitation (>3+)
7. Any concomitant valve disease that requires an intervention
8. Pre-existing mechanical or bioprosthetic valve in any position. (of note,
mitral ring is not an exclusion).
9. Complex coronary artery disease:
- Unprotected left main coronary artery stenosis
- Syntax score > 32 (in the absence of prior revascularization)
- Heart Team assessment that optimal revascularization cannot be performed.
10. Symptomatic carotid or vertebral artery disease or successful treatment of
carotid stenosis within 30 days before randomization
11. Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia
(Plt < 50,000 cell/mL), history of bleeding diathesis or coagulopathy, or
hypercoagulable states.
12. Hemodynamic or respiratory instability requiring inotropic support,
mechanical ventilation or mechanical heart assistance within 30 days before
randomization
13. Hypertrophic cardiomyopathy with obstruction (HOCM)
14. Ventricular dysfunction with LVEF < 30%
15. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass,
thrombus or vegetation
16. Inability to tolerate or condition precluding treatment with anti-
thrombotic/anticoagulation therapy during or after the valve implant procedure
17. Stroke or transient ischemic attack (TIA) within 90 days before
randomization
18. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula)
and/or renal replacement therapy
19. Active bacterial endocarditis within 180 days of randomization
20. Severe lung disease (FEV1 < 50%) or currently on home oxygen
21. Severe pulmonary hypertension (e.g., PA systolic pressure >= 2/3 systemic
pressure)
22. History of cirrhosis or any active liver disease
23. Significant abdominal or thoracic aortic disease (such as porcelain aorta,
aneurysm, severe calcification, aortic coarctation, etc.) that would preclude
safe passage of the delivery system or cannulation and aortotomy for surgical
AVR.
24. Hostile chest or conditions or complications from prior surgery that
preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal
chest wall, adhesion of aorta or IMA to sternum, etc.)
25. Patient refuses blood products
26. BMI > 50 kg/m2
27. Estimated life expectancy < 24 months
28. Absolute contraindications or allergy to iodinated contrast agent that
cannot be adequately treated with pre-medication
29. Immobility that would prevent completion of study procedures
30. Currently participating in an investigational drug or another device study.
31. Pregnancy or lactation
Note: Trials requiring extended follow-up for products that were
investigational, but have since become commercially available, are not
considered investigational trials. Observational studies are not considered
exclusionary.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical efficacy composite endpoint at 1 year post procedure:<br /><br>• All-cause mortality<br /><br>• All stroke (disabling and non-disabling)<br /><br>• Rehospitalization (valve-related or procedure-related or worsening congestive<br /><br>heart failure)</p><br>
- Secondary Outcome Measures
Name Time Method