Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
NCT ID: NCT02701283
Last Updated: 2025-10-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
2223 participants
INTERVENTIONAL
2016-03-31
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
NCT02628899
Medtronic CoreValve Evolut R U.S. Clinical Study
NCT02207569
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
NCT02746809
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
NCT01586910
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
NCT03112980
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
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
Surgical Aortic Valve Replacement (SAVR)
Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiovascular
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Reardon, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
John K. Forrest, MD
Role: PRINCIPAL_INVESTIGATOR
Yale New Haven Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
University of Southern California University Hospital
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
Mercy General Hospital
Sacramento, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Morton Plant Hospital
Clearwater, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
HealthPark Medical Center
Fort Myers, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Saint Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Mercy Medical Center
Des Moines, Iowa, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
Jewish Hospital
Louisville, Kentucky, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mercy Hospital
Springfield, Missouri, United States
Saint Francis Hospital
East Hills, New York, United States
Saint Joseph's Hospital Health Center
Liverpool, New York, United States
Northwell Health
Manhasset, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health Science University
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Geinsinger Medical Center
Danville, Pennsylvania, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Paramount Heart
Villanova, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, United States
Baylor Saint Luke's Medical Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Methodist Hospital San Antonio
San Antonio, Texas, United States
University Hospital Salt Lake City Utah
Salt Lake City, Utah, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
Saint Mary's Hospital
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Saint Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital (FSH)
Murdoch, Western Australia, Australia
London Health Sciences Centre
London, Ontario, Canada
Toronto General Health Hospital
Toronto, Ontario, Canada
Glen Royal Victoria (McGill)
Montreal, Quebec, Canada
IUCPQ
Québec, Quebec, Canada
Montreal Heart
Montreal, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
Centre Hospitalier Régional Universitaire de Lille
Lille, , France
L'Hôpital Privé Jacques Cartier Massy
Massy, , France
Clinique Pasteur
Toulouse, , France
Kokura Memorial Hospital
Kitakyushu, Fokuoka, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Teikyo University Hospital
Tokyo, Itabashi-Ku, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
National Cerebral and Cardiovasclular Center
Suita, Osaka, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Sakakibara Heart Institute
Fuchū, Tokyo, Japan
Catharina Ziekenhuis
Eindhoven, , Netherlands
St. Antonius Hospital Nieuwegein
Nieuwegein, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Waikato Hospital
Hamilton, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10234430Doc
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.