Clinical trial NCT04372381: Supra-Annular vs. Annular ValvEs for Small Annuli
Official title: Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Implantation, Heart Valve Prosthesis
Keywords: Implantation, Heart Valve Prosthesis
aortic valve stenosis
transcatheter aortic valve replacement
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2020-05-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-Label, Prospective randomized
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
timeFrame: 1 month
Secondary outcomes:
measure: VARC-2 30-day early safety and efficacy
timeFrame: 30 days
measure: Pacemaker implantation
timeFrame: 30 days
measure: Prosthetic Valve Dysfunction
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center, Phoenix campus
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
Study officials:
affiliation: University of Arizona
name: Marvin Eng, MD
role: PRINCIPAL_INVESTIGATOR
References: