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AzTrials

Severe Aortic StenosisSURTAVINCT01586910

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).

A study testing Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR) and Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) in people with Severe Aortic Stenosis, run by Medtronic Cardiovascular at 86 sites in 9 countries.

Active, not recruiting

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

Official record

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Trial summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve®… Read more about this study

Who is it for?
Any age
Conditions the study is for
Severe Aortic Stenosis
What is being tested?
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR) and Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,746 participants
Where
86 sitesin 9 countries
Study dates
Apr 2012to Nov 2026
Phase
Interventional

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

  • Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and <15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
  • Heart Team unanimously agree on treatment proposal and eligibility for randomization* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
  • Subject has severe aortic stenosis presenting with;
  • Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index < 0.6cm2/m2 AND
  • Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;
  • Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
  • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
  • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Who cannot join

  • Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
  • Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
  • A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
  • Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
  • Ongoing sepsis, including active endocarditis;
  • Any condition considered a contraindication to extracorporeal assistance;
Show all 40Show fewer
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization*;
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
  • Recent (within 6 months of randomization*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
  • Active 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);
  • Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
  • Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid 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 index procedure;
  • Need for emergency surgery for any reason;
  • True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
  • Extensive mediastinal radiation;
  • Liver failure (Child-C);
  • Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
  • Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
  • Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
  • End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
  • Pulmonary Hypertension (systolic pressure> 80mmHg);
  • Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
  • Frailty assessments identify:
  • Subject is < 80 years of age and three or more of the following apply
  • Subject is ≥ 80 years of age and two or more of the following apply
  • Wheelchair bound
  • Resides in an institutional care facility (e.g., nursing home, skilled care center)
  • Body Mass Index < 20 kg/m2
  • Grip Strength < 16 kg
  • Katz Index Score ≤ 4
  • Albumin < 3.5 g/dL;
  • Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)
  • Note: Additional anatomical and vascular exclusion criteria may apply.
  • Note: For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.

Trial locations and contacts

86 sites in 9 countries.

86 sites in 9 countries

United States65 sites

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109-5864

  • Emory University

    Atlanta, Georgia, 30308

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30309

  • The Johns Hopkins University

    Baltimore, Maryland, 21205

  • Beth Israel Deaconess Medical Center, Inc.

    Boston, Massachusetts, 02215

  • University of Vermont

    Burlington, Vermont, 05401

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Carolinas HealthCare System

    Charlotte, North Carolina, 28203

  • 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

  • The OhioHealth Research Institute

    Columbus, Ohio, 43214

  • University of Miami

    Coral Gables, Florida, 33146

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Delray Medical Center

    Delray Beach, Florida, 33484

  • Detroit Medical Center

    Detroit, Michigan, 48201-2018

  • Henry Ford

    Detroit, Michigan, 48202

  • St. John Hospital & Medical Center

    Detroit, Michigan, 48236

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Cedars-Sinai Medical Center

    Hollywood, California, 90048

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • The Methodist DeBakey Heart & Vascular Center

    Houston, Texas, 77030

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital/MAHI

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Loyola University of Chicago

    Maywood, Illinois, 60153

  • Stern Cardiovascular

    Memphis, Tennessee, 38120

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Abbott NW - MN Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • El Camino Hospital

    Mountain View, California, 94040

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520-8047

  • New York University School of Medicine

    New York, New York, 10016

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Lenox Hill Hospital

    New York, New York, 10075

  • Sentara Cardiovascular

    Norfolk, Virginia, 23507

  • Oklahoma Heart Institute

    Oklahoma City, Oklahoma, 73120

  • Alegent Creighton Health Research Center

    Omaha, Nebraska, 68124

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Southern California Permenente Medical Group

    Pasadena, California, 91101

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Heart Hospital - Baylor Plano

    Plano, Texas, 75093

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226

  • Mayo Clinic - St. Mary's Hospital

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Stanford University Medical Center

    Stanford, California, 94305

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Iowa Heart Center / Mercy Medical Center

    West Des Moines, Iowa, 50266

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Canada5 sites

  • London Health Sciences Centre, University Hospital

    London, Ontario

  • McGill University Health Center - Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Montreal Heart Institute

    Montreal

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Toronto General Hospital (University Health Network)

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Netherlands4 sites

  • Amphia Hospital Breda

    Breda

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • St. Antonius Hospital, R & D Cardiology

    Nieuwegein

  • Erasmus Medical Center - Rotterdam

    Rotterdam

Other trials in Netherlands

Germany3 sites

  • Universitäts-Herzzentrum Freiburg • Bad Krozingen

    Bad Krozingen, 79106

  • Universitätsklinikum Bonn

    Bonn

  • Deutsches Herzzentrum Muenchen

    Munich

Other trials in Germany

United Kingdom3 sites

  • Leeds General Infirmary

    Leeds

  • Glenfield Hospital, Leicester, UK

    Leicester, LE5 4PW

  • St. George's Hospital London

    London, SW170QT

Other trials in United Kingdom

Spain2 sites

  • Servicio de Cardiologia del Hospital Virgen de la Victoria

    Málaga

  • Hospital Universitario Central de Asturias

    Oviedo

Other trials in Spain

Switzerland2 sites

  • Bern University Hospital

    Bern

  • Universitatsspital Zurich

    Zurich

Other trials in Switzerland

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Sweden1 site

  • Karolinska Universitetssjukhuset Stockholm

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Being tested
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
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 CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)Device

  • Surgical Aortic Valve Replacement (SAVR)Procedure or surgery

  • Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)Device

Study groups in NCT01586910
Study groupRoleWhat they receive
Medtronic CoreValve® System TAVIExperimentalMedtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Receives: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
SAVRActive comparatorSurgical Aortic Valve Replacement (SAVR)
Receives: Procedure: Surgical Aortic Valve Replacement (SAVR)

What is being measured

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

  1. All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability

    All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths.

    Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.

    Measured: 24 months

Secondary outcomes (25)

  1. Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

    MACCE is defined as a composite of:

    • All-cause death
    • Myocardial infarction (MI)
    • All stroke, and
    • Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

    Measured: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  2. Percentage of Participants With Individual MACCE Components

    MACCE is defined as a composite of:

    • All-cause death
    • Myocardial infarction (MI)
    • All stroke, and
    • Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

    Measured: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  3. Percentage of Participants With Major Adverse Events (MAE)

    Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.

    Measured: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  4. Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation

    Measured: 30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  5. Change in NYHA Class From Baseline

    Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.

    New York Heart Association (NYHA) Classification:

    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.

    Measured: Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  6. Change in Distance Walked During 6-minute Walk Test (6MWT)

    Change in distance walked during 6MWT from baseline

    Measured: From baseline to 30 days, baseline to 12 months, and baseline to 24 months

  7. Ratio of Days Alive Out of Hospital Versus Total Days Alive

    Measured: 12 and 24 months

  8. Quality of Life (QoL) Change From Baseline

    QoL summary score change from baseline using the following measures:

    • Kansas City Cardiomyopathy Questionnaire (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.
    • 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
    • European QoL (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.

    Measured: Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  9. Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance

    Using the following measure:

    -Transvalvular mean gradient

    Measured: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

  10. Effective Orifice Area as an Assessment of Prosthetic Valve Performance

    Using the following measure:

    -Effective Orifice Area (cm^2)

    Measured: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

  11. Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance

    Using the following measure:

    • Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)

    Measured: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

  12. Percentage of Participants With Aortic Valve Disease Related Hospitalizations

    Measured: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  13. Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths

    Measured: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete

  14. Percentage of Participants With Stroke and TIAs

    Strokes (of any severity) and Transient Ischemic Attacks (TIAs)

    Measured: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  15. Peri-procedural Neurological Injury

    Neurological injury (stroke, TIA, or encephalopathy)

    Measured: discharge or 7 days post index procedure (whichever occurred first)

  16. Index Procedure Related Major Adverse Events (MAEs)

    Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.

    Measured: Procedure through 30 day visit

  17. Length of Index Procedure Hospital Stay

    Measured: Number of days from admission to discharge (expected average of 7 days)

  18. Presence of Atrial Fibrillation

    Measured: post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  19. Device Success (Medtronic CoreValve® System Subjects Only)

    • Absence of procedural mortality
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location
    • Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)

    Measured: Number of days from admission to discharge (expected average of 7 days)

  20. Procedural Success (Medtronic CoreValve® System Subjects Only)

    Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)

    Measured: Number of days from admission to discharge (expected average of 7 days)

  21. Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)

    Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered

    PVD defined as:

    • Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA <1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI <0. 35 m/s) OR
    • moderate or severe total AR

    Measured: 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.

  22. Percentage of Participants With Early Safety Endpoint

    Percentage of participants with VARC II early safety composite at 30 days

    Measured: 30 Days

  23. Percentage of Participants With Clinical Efficacy (After 30 Days)

    Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.

    Measured: 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete

  24. Percentage of Participants With Time-Related Safety

    The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI <0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.

    Measured: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.

  25. Resheath and Recapture Success (Evolut R Only)

    The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.

    Measured: Procedure

Timeline

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

  1. First posted27 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJul 2018
  4. Study completionNov 2026 (estimated)

Resources

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
1,746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586910
Sponsor's protocol ID
IDE #G120169
Acronym
SURTAVI
Status last verified
May 2026
First submitted
24 Apr 2012
Last updated
24 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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

  • Kleiman NS, Van Mieghem NM, Reardon MJ, Gada H, Mumtaz M, Olsen PS, Heiser J, Merhi W, Chetcuti S, Deeb GM, Chawla A, Kiaii B, Teefy P, Chu MWA, Yakubov SJ, Windecker S, Althouse AD, Baron SJ. Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients. JACC Cardiovasc Interv. 2024 Apr 22;17(8):979-988. doi: 10.1016/j.jcin.2024.02.014.

    PubMed 38658126

  • O'Hair D, Yakubov SJ, Grubb KJ, Oh JK, Ito S, Deeb GM, Van Mieghem NM, Adams DH, Bajwa T, Kleiman NS, Chetcuti S, Sondergaard L, Gada H, Mumtaz M, Heiser J, Merhi WM, Petrossian G, Robinson N, Tang GHL, Rovin JD, Little SH, Jain R, Verdoliva S, Hanson T, Li S, Popma JJ, Reardon MJ. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023 Feb 1;8(2):111-119. doi: 10.1001/jamacardio.2022.4627.

    PubMed 36515976

  • Tuttle MK, Kiaii B, Van Mieghem NM, Laham RJ, Deeb GM, Windecker S, Chetcuti S, Yakubov SJ, Chawla A, Hockmuth D, Teefy P, Li S, Reardon MJ. Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-Year Analysis From the SURTAVI Trial. JACC Cardiovasc Interv. 2022 Apr 11;15(7):728-738. doi: 10.1016/j.jcin.2022.01.284.

    PubMed 35393106

  • 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

  • Mumtaz M, Wyler von Ballmoos MC, Deeb GM, Popma JJ, Van Mieghem NM, Kleiman NS, Gleason TG, Chawla A, Hockmuth D, Zorn GL 3rd, Tadros P, Li S, Reardon MJ. The Impact of Transfusions on Mortality After Transcatheter or Surgical Aortic Valve Replacement. Ann Thorac Surg. 2021 Sep;112(3):778-785. doi: 10.1016/j.athoracsur.2020.09.031. Epub 2020 Nov 17.

    PubMed 33217396

  • Attizzani GF, Dallan LAP, Markowitz A, Yakubov SJ, Deeb GM, Reardon MJ, Forrest JK, Mangi AA, Huang J, Popma JJ. Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1816-1824. doi: 10.1016/j.jcin.2020.04.028.

    PubMed 32763073

  • Yakubov SJ, Van Mieghem NM, Reardon MJ, Serruys PW, Gada H, Mumtaz M, Deeb GM, Kodali S, George I, Windecker S, Kleiman N, Chetcuti SJ, Sanchez C, Dauerman HL, Li S, Popma JJ. Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial). Am J Cardiol. 2020 Sep 15;131:82-90. doi: 10.1016/j.amjcard.2020.06.051. Epub 2020 Jun 29.

    PubMed 32723555

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