Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Conditions
Keywords
Implantation, Heart Valve Prosthesis, aortic valve stenosis, transcatheter aortic valve replacement
Brief summary
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Detailed description
Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.
Interventions
DEVICETranscatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
Treatment of aortic valve stenosis using transcatheter aortic valve replacement
Sponsors
University of Arizona
Corewell Health East
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-Label, Prospective randomized
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Symptomatic subjects with severe native aortic valve stenosis * aortic valve annulus mean diameter ≤23 mm * Patient meet commercial indication for transcatheter aortic valve replacement (TAVR) * Institutional heart team determines that TAVR is appropriate * Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
Exclusion criteria
* Subject unable or unwilling to provide informed consent * Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure) * Renal function precluding the administration of iodinated contrast (eGFR \< 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media * Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures * Patients at high risk for coronary obstruction * Patients with low-flow low gradient aortic valve stenosis * patients at high risk for annular rupture with implantation of a balloon expandable valve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VARC-2 30-day early safety and efficacy | 30 days | All cause mortality stroke life-threatening bleeding acute kidney injury-stage 2 or 3 coronary artery obstruction major vascular complication valve-related dysfunction requiring repeat procedure NYHA class III or IV Requiring hospitalization for valve-related symptoms or worsening congestive heart failure |
| Pacemaker implantation | 30 days | Clinical indication for permanent pacemaker insertion |
| Prosthetic Valve Dysfunction | 30 days and 1 year | Mean aortic valve gradient \>= 20 mmHg \>= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarvin Eng, MD
University of Arizona
Outcome results
None listed