NL-OMON54270
Recruiting
Not Applicable
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 - RHEIA (Randomized researcH in womEn all comers wIth Aortic stenosis)
Optimapharm Deutschland GmbH (formerly: SSS International Clinical Research GmbH)0 sites80 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Optimapharm Deutschland GmbH (formerly: SSS International Clinical Research GmbH)
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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\+)
Outcomes
Primary Outcomes
Not specified
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