Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Medtronic Transcatheter Aortic Valve Replacement Systems; Device: Surgical Aortic Valve Replacement (SAVR)

Detailed Description

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.

• Study Type: Interventional
• Enrollment (Actual): 2223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Saint Vincent's Hospital Sydney
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital (FSH)
• Canada
  • Montreal, Canada, H1T 1C8
    • Montreal Heart
  • Toronto, Canada
    • Sunnybrook Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, MSG2C4
      • Toronto General Health Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Glen Royal Victoria (McGill)
    • Québec, Quebec, Canada, G1V 4G5
      • IUCPQ
• France
  • Lille, France, 59000
    • Centre Hospitalier Régional Universitaire de Lille
  • Massy, France, 91300
    • L'Hôpital Privé Jacques Cartier Massy
  • Toulouse, France, 31300
    • Clinique Pasteur
• Japan
  • Fokuoka
    • Kitakyushu, Fokuoka, Japan
      • Kokura Memorial Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Sapporo Higashi Tokushukai Hospital
  • Itabashi-Ku
    • Tokyo, Itabashi-Ku, Japan
      • Teikyo University Hospital
  • Kanagawa
    • Kamakura, Kanagawa, Japan
      • Shonan Kamakura General Hospital
  • Miyagi
    • Sendai, Miyagi, Japan
      • Sendai Kousei Hospital
  • Osaka
    • Suita, Osaka, Japan
      • National Cerebral and Cardiovasclular Center
    • Suita, Osaka, Japan
      • The University of Osaka Hospital
  • Tokyo
    • Fuchū, Tokyo, Japan
      • Sakakibara Heart Institute
• Netherlands
  • Eindhoven, Netherlands, 5623
    • Catharina Ziekenhuis
  • Nieuwegein, Netherlands, 3435
    • St. Antonius Hospital Nieuwegein
  • Rotterdam, Netherlands, 3015
    • Erasmus Medisch Centrum
• New Zealand
  • Hamilton, New Zealand
    • Waikato Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Abrazo Arizona Heart Hospital
  • California
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital La Jolla
    • Los Angeles, California, United States, 90033
      • University of Southern California University Hospital
    • Mountain View, California, United States, 64040
      • El Camino Hospital
    • Sacramento, California, United States, 95816
      • Mercy General Hospital
    • Thousand Oaks, California, United States, 91360
      • Los Robles Hospital & Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • Fort Myers, Florida, United States, 33908
      • HealthPark Medical Center
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Atlanta Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Saint Vincent Heart Center of Indiana
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Terrebonne General Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Detroit, Michigan, United States, 48236
      • Saint John Hospital and Medical Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • Missouri
    • Springfield, Missouri, United States, 65806
      • Mercy Hospital
  • New York
    • East Hills, New York, United States, 11548
      • Saint Francis Hospital
    • Liverpool, New York, United States, 13088
      • Saint Joseph's Hospital Health Center
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43214
      • OhioHealth Riverside Methodist Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Science University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Danville, Pennsylvania, United States, 17043
      • Geinsinger Medical Center
    • Harrisburg, Pennsylvania, United States, 17043
      • Pinnacle Health
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center UPMC Presbyterian
    • Villanova, Pennsylvania, United States, 19085
      • Paramount Heart
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75204
      • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • Baylor Saint Luke's Medical Center
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University Hospital Salt Lake City Utah
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Saint Mary's Hospital
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Severe aortic stenosis, defined as follows:

   1. For symptomatic patients:

      Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

   2. For asymptomatic patients:

      • Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).

2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

   1. aspirin or heparin (HIT/HITTS) and bivalirudin
   2. ticlopidine and clopidogrel
   3. Nitinol (titanium or nickel)
   4. contrast media
3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
4. Ongoing sepsis, including active endocarditis.
5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
11. Subject refuses a blood transfusion.
12. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
14. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
15. Currently participating in an investigational drug or another device trial (excluding registries).
16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
17. Need for emergency surgery for any reason.
18. Subject is pregnant or breast feeding.
19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
20. Pre-existing prosthetic heart valve in any position.
21. Severe mitral regurgitation amenable to surgical replacement or repair.
22. Severe tricuspid regurgitation amenable to surgical replacement or repair.
23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
26. Prohibitive left ventricular outflow tract calcification.
27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
28. Aortic annulus diameter of <18 or >30 mm.

29. Significant aortopathy requiring ascending aortic replacement.

    For transfemoral or transaxillary (subclavian) access:

30. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.

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
Experimental: Medtronic Transcatheter Aortic Valve Replacement Systems; Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Device: Medtronic Transcatheter Aortic Valve Replacement Systems; Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems
Active Comparator: Surgical Aortic Valve Replacement (SAVR); Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)	Device: Surgical Aortic Valve Replacement (SAVR); Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study	Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).	Randomized Controlled Trial - 24 months Continued Access Study - 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days	Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication	30 days
New Pacemaker Implantation at 30 Days	The rate of new permanent pacemaker implant at 30 days	30 days
Prosthetic Valve Endocarditis at 1 Year	The rate of prosthetic valve endocarditis at 1 year	1 year
Prosthetic Valve Thrombosis at 1 Year	The rate of prosthetic valve thrombosis at 1 year	1 year
All Stroke (Disabling and Non-disabling) at 1 Year	The rate of all stroke (disabling and non-disabling) at 1 year	1 year
Life-threatening Bleeding at 1 Year	The rate of life-threatening bleeding at 1 year	1 year
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year	The rate of valve-related dysfunction requiring repeat procedure at 1 year	1 year
Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial	Stenosis (moderate or severe) Any of the following: Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA <0.8 cm2; Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA ≥0.8 cm2, and DVI <0.25; Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA <0.8 cm2, and DVI <0.25 Regurgitation (moderate or severe) Any of the following: Moderate or Severe Total Regurgitation; Moderate or Severe Paravalvular Regurgitation; Moderate or Severe Transvalvular Regurgitation	1 year
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year	Quality of life summary scores and change from baseline using the following measures: KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year
Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial	The rate of repeat hospitalization for aortic valve disease at 1 year	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial	Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation	1 year
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year	Reporting of prosthetic valve hemodynamic performance by EOA	1 year
Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial	Quality of life summary scores and change from baseline using the following measures: EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state	1 year
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial	Reporting of NYHA classification at 1 year NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity Class I: Subjects with cardiac disease resulting in slight limitation of physical activity Class III: Subjects with cardiac disease resulting in marked limitation of physical activity Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort	1 year
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient	1 year
Efficacy: Device Success Rate	Assessment of procedural effectiveness by meeting all of the following device success criteria: Absence of procedural mortality, AND; Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND; Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)	Hospital discharge or 7 days post-procedure (whichever occurs first)

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Michael Reardon, MD, The Methodist Hospital Research Institute; Principal Investigator: John K. Forrest, MD, Yale New Haven Hospital

Publications and helpful links

General Publications

• Lanz J, Reardon MJ, Pilgrim T, Stortecky S, Deeb GM, Chetcuti S, Yakubov SJ, Gleason TG, Huang J, Windecker S. Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement. J Am Heart Assoc. 2021 Oct 5;10(19):e020368. doi: 10.1161/JAHA.120.020368. Epub 2021 Sep 28.
• Leipsic J, Bax JJ, Webb JG, Martin R, Blanke P. Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions. JACC Cardiovasc Imaging. 2017 Mar;10(3):286-295. doi: 10.1016/j.jcmg.2016.09.031.
• Ramlawi B, Deeb GM, Yakubov SJ, Markowitz AH, Hughes GC, Kiaii RB, Huang J, Kleiman NS, Reardon MJ. Mechanisms of Death in Low-Risk Patients After Transcatheter or Surgical Aortic Valve Replacement. Cardiovasc Revasc Med. 2022 Sep;42:1-5. doi: 10.1016/j.carrev.2022.03.027. Epub 2022 Mar 29.
• Forrest JK, Deeb GM, Yakubov SJ, Rovin JD, Mumtaz M, Gada H, O'Hair D, Bajwa T, Sorajja P, Heiser JC, Merhi W, Mangi A, Spriggs DJ, Kleiman NS, Chetcuti SJ, Teirstein PS, Zorn GL 3rd, Tadros P, Tchetche D, Resar JR, Walton A, Gleason TG, Ramlawi B, Iskander A, Caputo R, Oh JK, Huang J, Reardon MJ. 2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. J Am Coll Cardiol. 2022 Mar 8;79(9):882-896. doi: 10.1016/j.jacc.2021.11.062.
• Blanke P, Leipsic JA, Popma JJ, Yakubov SJ, Deeb GM, Gada H, Mumtaz M, Ramlawi B, Kleiman NS, Sorajja P, Askew J, Meduri CU, Kauten J, Melnitchouk S, Inglessis I, Huang J, Boulware M, Reardon MJ; Evolut Low Risk LTI Substudy Investigators. Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study. J Am Coll Cardiol. 2020 May 19;75(19):2430-2442. doi: 10.1016/j.jacc.2020.03.022. Epub 2020 Mar 28.
• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
• Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.
• Forrest JK, Yakubov SJ, Deeb GM, Gada H, Mumtaz MA, Ramlawi B, Bajwa T, Crouch J, Merhi W, Wai Sang SL, Kleiman NS, Petrossian G, Robinson NB, Sorajja P, Iskander A, Berthoumieu P, Tchetche D, Feindel C, Horlick EM, Saito S, Oh JK, Jung Y, Reardon MJ; Low Risk Trial Investigators. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2025 Apr 22;85(15):1523-1532. doi: 10.1016/j.jacc.2025.03.004. Epub 2025 Mar 30.
• Butala NM, Lalani C, Tale A, Song Y, Kolte D, Baron S, Strom J, Cohen DJ, Yeh RW. Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial. Circ Cardiovasc Interv. 2025 Jan;18(1):e014592. doi: 10.1161/CIRCINTERVENTIONS.124.014592. Epub 2025 Jan 21.
• Modine T, Tchetche D, Van Mieghem NM, Deeb GM, Chetcuti SJ, Yakubov SJ, Sorajja P, Gada H, Mumtaz M, Ramlawi B, Bajwa T, Crouch J, Teirstein PS, Kleiman NS, Iskander A, Bagur R, Chu MWA, Berthoumieu P, Sudre A, Adrichem R, Ito S, Huang J, Popma JJ, Forrest JK, Reardon MJ. Three-Year Outcomes Following TAVR in Younger (<75 Years) Low-Surgical-Risk Severe Aortic Stenosis Patients. Circ Cardiovasc Interv. 2024 Nov;17(11):e014018. doi: 10.1161/CIRCINTERVENTIONS.124.014018. Epub 2024 Oct 18.
• Tang GHL, Spencer J, Rogers T, Grubb KJ, Gleason P, Gada H, Mahoney P, Dauerman HL, Forrest JK, Reardon MJ, Blanke P, Leipsic JA, Abdel-Wahab M, Attizzani GF, Puri R, Caskey M, Chung CJ, Chen YH, Dudek D, Allen KB, Chhatriwalla AK, Htun WW, Blackman DJ, Tarantini G, Zhingre Sanchez J, Schwartz G, Popma JJ, Sathananthan J. Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study. Circ Cardiovasc Interv. 2023 Nov;16(11):e013238. doi: 10.1161/CIRCINTERVENTIONS.123.013238. Epub 2023 Nov 21.
• Grubb KJ, Shekiladze N, Spencer J, Perdoncin E, Tang GHL, Xie J, Lisko J, Sanchez JZ, Lucas LM, Sathananthan J, Rogers T, Deeb GM, Fukuhara S, Blanke P, Leipsic JA, Forrest JK, Reardon MJ, Gleason P. Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy. EuroIntervention. 2023 Jul 17;19(4):e330-e339. doi: 10.4244/EIJ-D-22-01125.
• Forrest JK, Deeb GM, Yakubov SJ, Gada H, Mumtaz MA, Ramlawi B, Bajwa T, Teirstein PS, DeFrain M, Muppala M, Rutkin BJ, Chawla A, Jenson B, Chetcuti SJ, Stoler RC, Poulin MF, Khabbaz K, Levack M, Goel K, Tchetche D, Lam KY, Tonino PAL, Ito S, Oh JK, Huang J, Popma JJ, Kleiman N, Reardon MJ; Low Risk Trial Investigators. 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2023 May 2;81(17):1663-1674. doi: 10.1016/j.jacc.2023.02.017. Epub 2023 Mar 5.
• Forrest JK, Yakubov SJ, Deeb GM, Reardon MJ; Evolut Low Risk Trial Investigators. Six-Year Outcomes After Transcatheter vs Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2026 Feb 16:S0735-1097(26)05423-9. doi: 10.1016/j.jacc.2026.02.5063. Online ahead of print.
• Erdem S, Goel SS, Reardon MJ. Five-year Outcomes of Transcatheter Aortic Valve Replacement Versus Surgery in Low-risk Aortic Stenosis: Insights from the Evolut Low Risk Trial. Heart Int. 2025 Nov 24;19(2):3-4. doi: 10.17925/HI.2025.19.2.5. eCollection 2025.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2021
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimated): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 10234430Doc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes