Supra-Annular vs. Annular ValvEs for Small Annuli (SAVE)

Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)

Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Valve Stenosis; Implantation, Heart Valve Prosthesis
• Intervention / Treatment: Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner - University Medical Center, Phoenix campus
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supra-Annular transcatheter heart valve; Medtronic Evolut Pro Valve implantation	Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro; Treatment of aortic valve stenosis using transcatheter aortic valve replacement
Active Comparator: Annular transcatheter heart valve; Edwards Sapien 3 Ultra implantation	Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro; Treatment of aortic valve stenosis using transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VARC-2 30-day early safety and efficacy	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	30 days
Pacemaker implantation	Clinical indication for permanent pacemaker insertion	30 days
Prosthetic Valve Dysfunction	Mean aortic valve gradient >= 20 mmHg >= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis	30 days and 1 year

Collaborators and Investigators

• Sponsor: Marvin Eng
• Collaborators: William Beaumont Hospitals
• Investigators: Principal Investigator: Marvin Eng, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: aortic valve stenosis; transcatheter aortic valve replacement; Implantation, Heart Valve Prosthesis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: STUDY00000164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No