NCT04372381

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)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

May 12, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 24, 2026

Status Verified

October 1, 2025

Enrollment Period

5 years

First QC Date

April 27, 2020

Last Update Submit

July 22, 2026

Conditions

Aortic Valve StenosisImplantation, Heart Valve Prosthesis

Keywords

Implantation, Heart Valve Prosthesisaortic valve stenosistranscatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation

    1 month

Secondary Outcomes (3)

  • VARC-2 30-day early safety and efficacy

    30 days

  • Pacemaker implantation

    30 days

  • Prosthetic Valve Dysfunction

    30 days and 1 year

Study Arms (2)

Supra-Annular transcatheter heart valve

ACTIVE COMPARATOR

Medtronic Evolut Pro Valve implantation

Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro

Annular transcatheter heart valve

ACTIVE COMPARATOR

Edwards Sapien 3 Ultra implantation

Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro

Interventions

Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut ProDEVICE

Treatment of aortic valve stenosis using transcatheter aortic valve replacement

Annular transcatheter heart valveSupra-Annular transcatheter heart valve

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Banner - University Medical Center, Phoenix campus

Phoenix, Arizona, 85006, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Marvin Eng, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open-Label, Prospective randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 4, 2020

Study Start

May 12, 2020

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

July 24, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)