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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04372381
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Marvin Eng, Henry Ford Health System

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)

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Implantation, Heart Valve Prosthesis Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-Label, Prospective randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
Estimated Study Start Date : May 4, 2020
Estimated Primary Completion Date : May 4, 2021
Estimated Study Completion Date : May 4, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. VARC-2 30-day early safety and efficacy [ Time Frame: 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

  2. Pacemaker implantation [ Time Frame: 30 days ]
    Clinical indication for permanent pacemaker insertion

  3. Prosthetic Valve Dysfunction [ Time Frame: 30 days and 1 year ]

    Mean aortic valve gradient >= 20 mmHg

    >= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372381


Contacts
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Contact: Kacorri, Ardit, MD 3139167452 ext 3139167452 akacorr1@hfhs.org

Locations
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United States, Michigan
Henry Ford Recruiting
Detroit, Michigan, United States, 48202
Contact: Marvin Eng, MD    313-207-5515 ext 3132075515    meng1@hfhs.org   
Sponsors and Collaborators
Marvin Eng
William Beaumont Hospitals
Investigators
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Principal Investigator: Marvin Eng Henry Ford Hospital
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Responsible Party: Marvin Eng, Structural Heart Disease Fellowship Director, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT04372381    
Other Study ID Numbers: 55
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Marvin Eng, Henry Ford Health System:
Implantation, Heart Valve Prosthesis
aortic valve stenosis
transcatheter aortic valve replacement
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction