Aortic Valve StenosisNCT02701283

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

A study testing Medtronic Transcatheter Aortic Valve Replacement Systems and Surgical Aortic Valve Replacement (SAVR) in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 87 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: Medtronic Transcatheter Aortic Valve Replacement Systems and Surgical Aortic Valve Replacement (SAVR)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,223 participants
Where: 87 sitesin 7 countries
Study dates: Mar 2016to Jun 2029
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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

Show all 35Show fewer

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.
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).
Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
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.
Currently participating in an investigational drug or another device trial (excluding registries).
Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
Need for emergency surgery for any reason.
Subject is pregnant or breast feeding.
Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
Pre-existing prosthetic heart valve in any position.
Severe mitral regurgitation amenable to surgical replacement or repair.
Severe tricuspid regurgitation amenable to surgical replacement or repair.
Moderate or severe mitral stenosis amenable to surgical replacement or repair.
Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
Prohibitive left ventricular outflow tract calcification.
Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
Aortic annulus diameter of <18 or >30 mm.
Significant aortopathy requiring ascending aortic replacement.
For transfemoral or transaxillary (subclavian) access:
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.

Trial locations and contacts

87 sites in 7 countries.

Country

City, postcode or hospital

87 sites in 7 countries

United States61 sites

Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
University of Michigan Health System
Ann Arbor, Michigan, 48109
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
University of Colorado Hospital
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
The University of Vermont Medical Center
Burlington, Vermont, 05401
Medical University of South Carolina
Charleston, South Carolina, 29425
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Morton Plant Hospital
Clearwater, Florida, 33756
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75204
Geinsinger Medical Center
Danville, Pennsylvania, 17043
Delray Medical Center
Delray Beach, Florida, 33484
Mercy Medical Center
Des Moines, Iowa, 50314
Saint John Hospital and Medical Center
Detroit, Michigan, 48236
Duke University Medical Center
Durham, North Carolina, 27710
Saint Francis Hospital
East Hills, New York, 11548
Sanford Medical Center
Fargo, North Dakota, 58102
HealthPark Medical Center
Fort Myers, Florida, 33908
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503
Pinnacle Health
Harrisburg, Pennsylvania, 17043
Terrebonne General Medical Center
Houma, Louisiana, 70360
Baylor Saint Luke's Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Saint Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
The University of Kansas Hospital
Kansas City, Kansas, 66160
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037
Saint Joseph's Hospital Health Center
Liverpool, New York, 13088
University of Southern California University Hospital
Los Angeles, California, 90033
Jewish Hospital
Louisville, Kentucky, 40202
Northwell Health
Manhasset, New York, 11030
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami Hospital
Miami, Florida, 33136
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
El Camino Hospital
Mountain View, California, 64040
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06520
The Mount Sinai Hospital
New York, New York, 10029
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15232
Oregon Health Science University
Portland, Oregon, 97239
Saint Mary's Hospital
Richmond, Virginia, 23226
Strong Memorial Hospital
Rochester, New York, 14642
Mercy General Hospital
Sacramento, California, 95816
University Hospital Salt Lake City Utah
Salt Lake City, Utah, 84132
Methodist Hospital San Antonio
San Antonio, Texas, 78229
Swedish Medical Center
Seattle, Washington, 98122
Baystate Medical Center
Springfield, Massachusetts, 01199
Mercy Hospital
Springfield, Missouri, 65806
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Paramount Heart
Villanova, Pennsylvania, 19085
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157

Other trials in United States

Japan8 sites

Sakakibara Heart Institute
Fuchū, Tokyo
Shonan Kamakura General Hospital
Kamakura, Kanagawa
Kokura Memorial Hospital
Kitakyushu, Fokuoka
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido
Sendai Kousei Hospital
Sendai, Miyagi
National Cerebral and Cardiovasclular Center
Suita, Osaka
The University of Osaka Hospital
Suita, Osaka
Teikyo University Hospital
Tokyo, Itabashi-Ku

Other trials in Japan

Canada6 sites

London Health Sciences Centre
London, Ontario, N6A 5A5
Glen Royal Victoria (McGill)
Montreal, Quebec, H4A 3J1
Montreal Heart
Montreal, H1T 1C8
IUCPQ
Québec, Quebec, G1V 4G5
Toronto General Health Hospital
Toronto, Ontario, MSG2C4
Sunnybrook Health Sciences Centre
Toronto

Other trials in Canada

Australia5 sites

Monash Health
Clayton, Victoria, 3168
Saint Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
The Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital (FSH)
Murdoch, Western Australia, 6150
Royal North Shore Hospital
St Leonards, New South Wales, 2065

Other trials in Australia

France3 sites

Centre Hospitalier Régional Universitaire de Lille
Lille, 59000
L'Hôpital Privé Jacques Cartier Massy
Massy, 91300
Clinique Pasteur
Toulouse, 31300

Other trials in France

Netherlands3 sites

Catharina Ziekenhuis
Eindhoven, 5623
St. Antonius Hospital Nieuwegein
Nieuwegein, 3435
Erasmus Medisch Centrum
Rotterdam, 3015

Other trials in Netherlands

New Zealand1 site

Waikato Hospital
Hamilton

Other trials in New Zealand

About this study

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

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.

Read the 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.

Conditions: Aortic Valve Stenosis
Being tested: Medtronic Transcatheter Aortic Valve Replacement Systems, Surgical Aortic Valve Replacement (SAVR)
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtronic Transcatheter Aortic Valve Replacement SystemsDevice
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)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

Study groups in NCT02701283
Study group	Role	What they receive
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) Receives: 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) Receives: Device: Surgical Aortic Valve Replacement (SAVR)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
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
Measured: 30 days
New Pacemaker Implantation at 30 Days
The rate of new permanent pacemaker implant at 30 days
Measured: 30 days
Prosthetic Valve Endocarditis at 1 Year
The rate of prosthetic valve endocarditis at 1 year
Measured: 1 year
Prosthetic Valve Thrombosis at 1 Year
The rate of prosthetic valve thrombosis at 1 year
Measured: 1 year
All Stroke (Disabling and Non-disabling) at 1 Year
The rate of all stroke (disabling and non-disabling) at 1 year
Measured: 1 year
Life-threatening Bleeding at 1 Year
The rate of life-threatening bleeding at 1 year
Measured: 1 year
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year
The rate of valve-related dysfunction requiring repeat procedure at 1 year
Measured: 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:
1. Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA <0.8 cm2
2. Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA ≥0.8 cm2, and DVI <0.25
3. 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:
1. Moderate or Severe Total Regurgitation
2. Moderate or Severe Paravalvular Regurgitation
3. Moderate or Severe Transvalvular Regurgitation
Measured: 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.
Measured: 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
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jun 2029

First posted8 Mar 2016 (estimated)
Study startMar 2016
Primary completionApr 2021
Study completionJun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02701283
Sponsor's protocol ID: 10234430Doc
Status last verified: Oct 2026
First submitted: 26 Feb 2016
Last updated: 2 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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 Jun 16;87(23):3210-3221. doi: 10.1016/j.jacc.2026.02.5063. Epub 2026 Feb 16.
PubMed 41697183
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.
PubMed 41377641
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.
PubMed 40158212
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.
PubMed 39836743
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.
PubMed 39421943
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.
PubMed 38710669
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.
PubMed 37988439
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.
PubMed 37067193
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.
PubMed 36882136
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.
PubMed 35398007
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.
PubMed 35241222
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.
PubMed 34581194
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.
PubMed 32234463
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.
PubMed 30883053
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.
PubMed 28279376

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
ClinicalTrials.gov ID: NCT02701283
Acronym / sponsor ID: 10234430Doc
Conditions: Aortic Valve Stenosis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,223 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: Apr 2021 (actual)
Study completion: Jun 2029 (estimated)
First posted: 8 Mar 2016 (estimated)
Results: Posted 9 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Medtronic Transcatheter Aortic Valve Replacement Systems	Experimental	Device: Medtronic Transcatheter Aortic Valve Replacement SystemsTreatment 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)
Surgical Aortic Valve Replacement (SAVR)	Active comparator	Device: Surgical Aortic Valve Replacement (SAVR)Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Severe aortic stenosis, defined as follows:
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
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.

Key exclusion criteria (35 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic Transcatheter Aortic Valve Replacement SystemsTreatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems	Device	Medtronic Transcatheter Aortic Valve Replacement 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	Device	Surgical Aortic Valve Replacement (SAVR)

Primary outcome

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
Time frame: Randomized Controlled Trial - 24 months Continued Access Study - 12 months
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).

10 secondary outcomes

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
Time frame: 30 days
New Pacemaker Implantation at 30 Days
Time frame: 30 days
Prosthetic Valve Endocarditis at 1 Year
Time frame: 1 year
Prosthetic Valve Thrombosis at 1 Year
Time frame: 1 year
All Stroke (Disabling and Non-disabling) at 1 Year
Time frame: 1 year
Life-threatening Bleeding at 1 Year
Time frame: 1 year
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year
Time frame: 1 year
Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial
Time frame: 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
Time frame: 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
Time frame: 1 year

Results and safety

Results posted to the registry on 9 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized Controlled Trial - Medtronic TAVR Systems	737	668
Randomized Controlled Trial - SAVR	741	579
Continued Access Study - Medtronic TAVR Systems	745	724

Primary outcome: 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

Time frame: Randomized Controlled Trial - 24 months Continued Access Study - 12 months. Number. Unit: Percent of participants (K-M rate)

Measure	Randomized Controlled Trial - Medtronic TAVR Systems n = 730	Randomized Controlled Trial - SAVR n = 684	Continued Access Study - Medtronic TAVR Systems n = 745
Value	4.3	6.3	5.7

Randomized Controlled Trial - Medtronic TAVR Systems vs Randomized Controlled Trial - SAVR: Posterior Median of the Difference: 0.999, Bayesian

Population analysed: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized Controlled Trial - Medtronic TAVR Systems	459 of 730 (62.9%)	474 of 730 (64.9%)	25 of 730
Randomized Controlled Trial - SAVR	495 of 684 (72.4%)	571 of 684 (83.5%)	29 of 684
Continued Access Study - Medtronic TAVR Systems	429 of 745 (57.6%)	0 of 745 (0%)	19 of 745

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41697183Forrest 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 Jun 16;87(23):3210-3221. doi: 10.1016/j.jacc.2026.02.5063. Epub 2026 Feb 16.
Derived from this study: PubMed 41377641Erdem 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.
Derived from this study: PubMed 40158212Forrest 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.
Derived from this study: PubMed 39836743Butala 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.
Derived from this study: PubMed 39421943Modine 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.
Derived from this study: PubMed 38710669Klautz 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.
Derived from this study: PubMed 37988439Tang 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.
Derived from this study: PubMed 37067193Grubb 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.
Derived from this study: PubMed 36882136Forrest 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.
Derived from this study: PubMed 35398007Ramlawi 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.
Derived from this study: PubMed 35241222Forrest 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.
Derived from this study: PubMed 34581194Lanz 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Reardon, MD principal investigator

The Methodist Hospital Research Institute

John K. Forrest, MD principal investigator

Yale New Haven Hospital

87 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Japan, Canada, Australia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Randomized Controlled Trial - 24 months Continued Access Study - 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02701283, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.