Aortic valve stenosis Small aortic annulus
Conditions
Interventions
All randomized and treated subjects will undergo a 5*year follow*up period. For
each subject, data will be collected at pre* and post*procedure, at discharge,
at 30 days and once a year until the 5*
Sponsors
Medtronic, Inc
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: I1. Symptomatic subjects with predicted risk of operative mortality =40 mmHg, OR maximal aortic valve velocity >=4.0 m/sec by transthoracic echocardiography at rest I3. Aortic valve annulus area
Exclusion criteria
Exclusion criteria: E1. Estimated life expectancy of less than 2 years E2. Multivessel coronary artery disease with a Syntax score >32 and/or unprotected left main coronary artery. E3. Participating in another trial that may influence the outcome of this trial E4. Need for an emergent procedure for any reason E5. Contraindicated for treatment with the Medtronic and Edwards TAV systems in accordance with the Instructions for Use E6. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams E7. Pregnant, nursing or planning to be pregnant. E8. Subject is less than legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable E9. Subject has an active COVID-19 infection or relevant history of COVID-19. Note: An active COVID-19 infection is defined as a positive Polymerase Chain Reaction (PCR) result. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19 that was less than 3 months prior to enrollment. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 3 months prior to enrollment. E10. Previous aortic valve replacement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+/Fx System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure. Primary Endpoints The trial will have two powered co-primary endpoints comparing the Medtronic SE TAVs and Edwards BE TAVs to: 1. A clinical outcome composite endpoint of mortality, disabling stroke or heart failure rehospitalization at 12 months. 2. A valve function composite endpoint of BVD at 12 months including any of the following: * HSVD: hemodynamic mean gradient >= 20mmHg * NSVD: severe PPM, >= moderate AR * Thrombosis * Endocarditis * Aortic valve re-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the trial is to generate long-term valve function data for both SE and BE TAVR through 5 years of follow-up. Powered Secondary Endpoints The powered secondary endpoints for the trial comparing the SE and BE TAVR are: - BVD in female subjects at 12 months - HSVD at 12 months - Hemodynamic mean gradient as continuous variable at 12 months - Effective orifice area (EOA) as continuous variable at 12 months - Moderate or severe prothesis-patient mismatch (PPM) at 30 days Non-powered Secondary Endpoints pls see point 5.2.3 in CIP | — |
Countries
Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactI Roijakkers
Medtronic
Outcome results
None listed