Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Recruiting

Conditions: 10046973
degenerative aortic valve bioprosthesis

Registration Number: NL-OMON50789

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

o Age >= 65 years
o Failing surgical aortic bioprosthesis requiring valve replacement and
eligible for transfemoral TAVI per heart team consensus based on multi-modality
imaging assessment (including echocardiography and multidetector CT).
o Written informed consent

Exclusion Criteria

o Not eligible for Transfemoral TAVI with SAPIEN3 and Evolut R/Pro
o Multi-valve defects requiring intervention
o Clinically unstable and/or inotropic/vasopressor /mechanical support.
o Known mural thrombus in the left ventricle
o Presence of a mechanical aortic valve
o History of recent (within 1 month) stroke or TIA

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is device success by VARC-II at 30 days, defined by:<br /><br>- Absence of procedural mortality AND<br /><br>- Correct positioning of a single prosthetic heart valve into the proper<br /><br>anatomical location AND<br /><br>- Intended performance of the prosthetic heart valve (no prosthesis- patient<br /><br>mismatch and mean aortic valve gradient < 20 mmHg or peak velocity<br /><br>< 3 m/s, AND no moderate or severe prosthetic valve regurgitation)<br /><br>- Clinically significant prosthesis patient mismatch is defined by EOAi < 0.85<br /><br>cm2/m2 (< 0.70 if BMI > 30kg/m2).<br /><br><br /><br>Co-primary endpoint is efficacy at 1 year defined by the composite of all-cause<br /><br>death, disabling stroke and rehospitalization for valve related problems. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical endpoints as defined by the most recent VARC document will be<br /><br>collected in an eCRF (including need for permanent pacemaker).<br /><br><br /><br>Cardiovascular rehospitalisation<br /><br>Coronary obstruction requiring intervention/operation<br /><br>New conduction disorders<br /><br><br /><br>Prosthetic valve function, as measured by trans thoracic echocardiography:<br /><br>- Left ventricular ejection fraction (%)<br /><br>- Peak velocity (m/s)<br /><br>- Mean gradient (mmHg)<br /><br>- Effective orifice area (cm2)<br /><br>- Indexed effective orifice area (m2/cm2)<br /><br>- Prosthetic aortic valve regurgitation </p><br>