Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

NCT02701283 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 10234430Doc
• Study Type: interventional
• Target: 2,223
• Locations: 7 countries
• Sites: 87

Brief Summary

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

  30 days

• New Pacemaker Implantation at 30 Days

  30 days

• Prosthetic Valve Endocarditis at 1 Year

  1 year

• Prosthetic Valve Thrombosis at 1 Year

  1 year

• All Stroke (Disabling and Non-disabling) at 1 Year

  1 year

Other Outcomes (6)

• Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial

  1 year

• Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year

  1 year

• Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial

  1 year

Study Arms (2)

Medtronic Transcatheter Aortic Valve Replacement Systems

EXPERIMENTAL

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

Surgical Aortic Valve Replacement (SAVR)

ACTIVE COMPARATOR

Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)

Device: Surgical Aortic Valve Replacement (SAVR)

Interventions

Medtronic Transcatheter Aortic Valve Replacement Systems DEVICE

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

Medtronic Transcatheter Aortic Valve Replacement Systems

Surgical Aortic Valve Replacement (SAVR) DEVICE

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

Surgical Aortic Valve Replacement (SAVR)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe aortic stenosis, defined as follows:
• 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
• 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%.
• 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.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

You may not qualify if:

• Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
• A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:
• aspirin or heparin (HIT/HITTS) and bivalirudin
• ticlopidine and clopidogrel
• Nitinol (titanium or nickel)
• contrast media
• Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• Ongoing sepsis, including active endocarditis.
• 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.
• Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery.
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• Subject refuses a blood transfusion.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (87)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States

Location

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

Location

University of Southern California University Hospital

Los Angeles, California, 90033, United States

Location

El Camino Hospital

Mountain View, California, 64040, United States

Location

Mercy General Hospital

Sacramento, California, 95816, United States

Location

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

HealthPark Medical Center

Fort Myers, Florida, 33908, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Tallahassee Research Institute, Inc.

Tallahassee, Florida, 32308, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Saint Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mercy Hospital

Springfield, Missouri, 65806, United States

Location

Saint Francis Hospital

East Hills, New York, 11548, United States

Location

Saint Joseph's Hospital Health Center

Liverpool, New York, 13088, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Medical Center

Fargo, North Dakota, 58102, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Geinsinger Medical Center

Danville, Pennsylvania, 17043, United States

Location

Pinnacle Health

Harrisburg, Pennsylvania, 17043, United States

Location

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15232, United States

Location

Paramount Heart

Villanova, Pennsylvania, 19085, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, 75204, United States

Location

Baylor Saint Luke's Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Methodist Hospital San Antonio

San Antonio, Texas, 78229, United States

Location

University Hospital Salt Lake City Utah

Salt Lake City, Utah, 84132, United States

Location

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Saint Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Saint Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Fiona Stanley Hospital (FSH)

Murdoch, Western Australia, 6150, Australia

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Toronto General Health Hospital

Toronto, Ontario, MSG2C4, Canada

Location

Glen Royal Victoria (McGill)

Montreal, Quebec, H4A 3J1, Canada

Location

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

Montreal Heart

Montreal, H1T 1C8, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Canada

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59000, France

Location

L'Hôpital Privé Jacques Cartier Massy

Massy, 91300, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Kokura Memorial Hospital

Kitakyushu, Fokuoka, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Location

Teikyo University Hospital

Tokyo, Itabashi-Ku, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Location

National Cerebral and Cardiovasclular Center

Suita, Osaka, Japan

Location

The University of Osaka Hospital

Suita, Osaka, Japan

Location

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Location

Catharina Ziekenhuis

Eindhoven, 5623, Netherlands

Location

St. Antonius Hospital Nieuwegein

Nieuwegein, 3435, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015, Netherlands

Location

Waikato Hospital

Hamilton, New Zealand

Location

Related Publications (15)

• 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.

  PMID: 41697183 DERIVED

• 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.

  PMID: 41377641 DERIVED

• 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.

  PMID: 40158212 DERIVED

• 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.

  PMID: 39836743 DERIVED

• 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.

  PMID: 39421943 DERIVED

• 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.

  PMID: 38710669 DERIVED

• 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.

  PMID: 37988439 DERIVED

• 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.

  PMID: 37067193 DERIVED

• 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.

  PMID: 36882136 DERIVED

• 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.

  PMID: 35398007 DERIVED

• 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.

  PMID: 35241222 DERIVED

• 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.

  PMID: 34581194 DERIVED

• 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.

  PMID: 32234463 DERIVED

• 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.

  PMID: 30883053 DERIVED

• 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.

  PMID: 28279376 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Kristin Smith, Clinical Research Manager
• Organization: Medtronic Structural Heart & Aortic Clinical Research & Medical Science

kristin.m.smith@medtronic.com

763-526-3095

Study Officials

• Michael Reardon, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• John K. Forrest, MD

  Yale New Haven Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2021
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 19, 2026
• Results First Posted: September 9, 2021

Record last verified: 2026-03

Locations

NZ (1); JP (8); US (61); FR (3); NL (3); AU (5); CA (6)