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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). (SURTAVI)

Primary Purpose

Severe Aortic Stenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Surgical Aortic Valve Replacement (SAVR)
Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Aortic Stenosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

    1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index < 0.6cm2/m2 AND
    2. 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;

Exclusion Criteria:

  • 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;
  • 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:

    1. Subject is < 80 years of age and three or more of the following apply
    2. 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.

Sites / Locations

  • Banner Good Samaritan Medical Center
  • Cedars-Sinai Medical Center
  • Scripps Green Hospital
  • Keck Medical Center of USC
  • El Camino Hospital
  • VA Palo Alto Health Care System
  • Southern California Permenente Medical Group
  • Stanford University Medical Center
  • Hartford Hospital
  • Yale New Haven Hospital
  • Washington Hospital Center
  • Morton Plant Hospital
  • University of Miami
  • Delray Medical Center
  • Emory University
  • Piedmont Healthcare, Inc.
  • The Queen's Medical Center
  • Loyola University of Chicago
  • St. Vincent Heart Center of Indiana
  • Iowa Heart Center / Mercy Medical Center
  • University of Kansas Hospital
  • Cardiovascular Institute of the South
  • The Johns Hopkins University
  • Beth Israel Deaconess Medical Center, Inc.
  • University of Michigan Health Systems
  • Detroit Medical Center
  • Henry Ford
  • St. John Hospital & Medical Center
  • Spectrum Health Hospitals
  • Abbott NW - MN Heart Institute Foundation
  • Mayo Clinic - St. Mary's Hospital
  • Saint Luke's Hospital/MAHI
  • Alegent Creighton Health Research Center
  • Cooper University Hospital
  • Morristown Medical Center
  • North Shore University Hospital
  • Winthrop University Hospital
  • New York University School of Medicine
  • Mount Sinai School of Medicine
  • Columbia University Medical Center
  • Lenox Hill Hospital
  • University of Rochester
  • St. Francis Hospital
  • Carolinas HealthCare System
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • Good Samaritan Hospital
  • University Hospitals Case Medical Center
  • The Ohio State University
  • The OhioHealth Research Institute
  • Oklahoma Heart Institute
  • Geisinger Medical Center
  • University of Pennsylvania Health System
  • University of Pittsburgh Medical Center
  • Pinnacle Health Cardiovascular Institute
  • Stern Cardiovascular
  • Vanderbilt University Medical Center
  • Baylor Heart and Vascular Hospital
  • The Methodist DeBakey Heart & Vascular Center
  • The Heart Hospital - Baylor Plano
  • Intermountain Medical Center
  • University of Vermont
  • Sentara Cardiovascular
  • Bon Secours St. Mary's Hospital
  • Aurora St. Luke's Medical Center
  • London Health Sciences Centre, University Hospital
  • Sunnybrook Research Institute
  • Toronto General Hospital (University Health Network)
  • McGill University Health Center - Royal Victoria Hospital
  • Montreal Heart Institute
  • Rigshospitalet
  • Universitäts-Herzzentrum Freiburg • Bad Krozingen
  • Universitätsklinikum Bonn
  • Deutsches Herzzentrum Muenchen
  • Amphia Hospital Breda
  • Medisch Centrum Leeuwarden
  • St. Antonius Hospital, R & D Cardiology
  • Erasmus Medical Center - Rotterdam
  • Servicio de Cardiologia del Hospital Virgen de la Victoria
  • Hospital Universitario Central de Asturias
  • Karolinska Universitetssjukhuset Stockholm
  • Bern University Hospital
  • Universitatsspital Zurich
  • Leeds General Infirmary
  • Glenfield Hospital, Leicester, UK
  • St. George's Hospital London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medtronic CoreValve® System TAVI

SAVR

Arm Description

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Surgical Aortic Valve Replacement (SAVR)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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.
Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
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.
Change in Distance Walked During 6-minute Walk Test (6MWT)
Change in distance walked during 6MWT from baseline
Ratio of Days Alive Out of Hospital Versus Total Days Alive
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.
Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance
Using the following measure: -Transvalvular mean gradient
Effective Orifice Area as an Assessment of Prosthetic Valve Performance
Using the following measure: -Effective Orifice Area (cm^2)
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
Using the following measure: - Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Percentage of Participants With Aortic Valve Disease Related Hospitalizations
Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths
Percentage of Participants With Stroke and TIAs
Strokes (of any severity) and Transient Ischemic Attacks (TIAs)
Peri-procedural Neurological Injury
Neurological injury (stroke, TIA, or encephalopathy)
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.
Length of Index Procedure Hospital Stay
Presence of Atrial Fibrillation
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)
Procedural Success (Medtronic CoreValve® System Subjects Only)
Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)
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
Percentage of Participants With Early Safety Endpoint
Percentage of participants with VARC II early safety composite at 30 days
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.
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.
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.

Full Information

First Posted
April 24, 2012
Last Updated
October 17, 2023
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01586910
Brief Title
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).
Acronym
SURTAVI
Official Title
Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2012 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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® 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Aortic Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medtronic CoreValve® System TAVI
Arm Type
Experimental
Arm Description
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Arm Title
SAVR
Arm Type
Active Comparator
Arm Description
Surgical Aortic Valve Replacement (SAVR)
Intervention Type
Device
Intervention Name(s)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Intervention Type
Procedure
Intervention Name(s)
Surgical Aortic Valve Replacement (SAVR)
Intervention Type
Device
Intervention Name(s)
Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Primary Outcome Measure Information:
Title
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Description
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)
Time Frame
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Percentage of Participants With Individual MACCE Components
Description
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)
Time Frame
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Percentage of Participants With Major Adverse Events (MAE)
Description
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.
Time Frame
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
Time Frame
30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Change in NYHA Class From Baseline
Description
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.
Time Frame
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.
Title
Change in Distance Walked During 6-minute Walk Test (6MWT)
Description
Change in distance walked during 6MWT from baseline
Time Frame
From baseline to 30 days, baseline to 12 months, and baseline to 24 months
Title
Ratio of Days Alive Out of Hospital Versus Total Days Alive
Time Frame
12 and 24 months
Title
Quality of Life (QoL) Change From Baseline
Description
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.
Time Frame
Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance
Description
Using the following measure: -Transvalvular mean gradient
Time Frame
discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Title
Effective Orifice Area as an Assessment of Prosthetic Valve Performance
Description
Using the following measure: -Effective Orifice Area (cm^2)
Time Frame
discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Title
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
Description
Using the following measure: - Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Time Frame
discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Title
Percentage of Participants With Aortic Valve Disease Related Hospitalizations
Time Frame
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths
Time Frame
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Title
Percentage of Participants With Stroke and TIAs
Description
Strokes (of any severity) and Transient Ischemic Attacks (TIAs)
Time Frame
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Peri-procedural Neurological Injury
Description
Neurological injury (stroke, TIA, or encephalopathy)
Time Frame
discharge or 7 days post index procedure (whichever occurred first)
Title
Index Procedure Related Major Adverse Events (MAEs)
Description
Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.
Time Frame
Procedure through 30 day visit
Title
Length of Index Procedure Hospital Stay
Time Frame
Number of days from admission to discharge (expected average of 7 days)
Title
Presence of Atrial Fibrillation
Time Frame
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.
Title
Device Success (Medtronic CoreValve® System Subjects Only)
Description
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)
Time Frame
Number of days from admission to discharge (expected average of 7 days)
Title
Procedural Success (Medtronic CoreValve® System Subjects Only)
Description
Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame
Number of days from admission to discharge (expected average of 7 days)
Title
Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)
Description
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
Time Frame
6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Title
Percentage of Participants With Early Safety Endpoint
Description
Percentage of participants with VARC II early safety composite at 30 days
Time Frame
30 Days
Title
Percentage of Participants With Clinical Efficacy (After 30 Days)
Description
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.
Time Frame
6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Title
Percentage of Participants With Time-Related Safety
Description
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.
Time Frame
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.
Title
Resheath and Recapture Success (Evolut R Only)
Description
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.
Time Frame
Procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, MD, PhD
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rüdiger Lange, MD, PhD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Walther, MD, PhD
Organizational Affiliation
Kerckhoff Klinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Reardon, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David H. Adams, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas M. Van Mieghem, MD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick W. Serruys, MD, PhD
Organizational Affiliation
National Heart & Lung Institute of Imperial College in London
Official's Role
Study Chair
Facility Information:
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Southern California Permenente Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8047
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Healthcare, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Loyola University of Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Iowa Heart Center / Mercy Medical Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5864
Country
United States
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2018
Country
United States
Facility Name
Henry Ford
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Abbott NW - MN Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic - St. Mary's Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Hospital/MAHI
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Alegent Creighton Health Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Carolinas HealthCare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oklahoma Heart Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Stern Cardiovascular
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
The Methodist DeBakey Heart & Vascular Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital - Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Sentara Cardiovascular
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Bon Secours St. Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital (University Health Network)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
McGill University Health Center - Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
Country
Canada
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Universitäts-Herzzentrum Freiburg • Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
Country
Germany
Facility Name
Amphia Hospital Breda
City
Breda
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
St. Antonius Hospital, R & D Cardiology
City
Nieuwegein
Country
Netherlands
Facility Name
Erasmus Medical Center - Rotterdam
City
Rotterdam
Country
Netherlands
Facility Name
Servicio de Cardiologia del Hospital Virgen de la Victoria
City
Malaga
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Karolinska Universitetssjukhuset Stockholm
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Bern University Hospital
City
Bern
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
Country
Switzerland
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
Glenfield Hospital, Leicester, UK
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
St. George's Hospital London
City
London
ZIP/Postal Code
SW170QT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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Citation
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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.
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PubMed Identifier
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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.
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PubMed Identifier
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Results Reference
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Learn more about this trial

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).

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