Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

Medtronic Cardiovascular86 sites in 1 country1,746 target enrollmentApril 1, 2012

ConditionsSevere Aortic Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Severe Aortic Stenosis
Sponsor: Medtronic Cardiovascular
Enrollment: 1746
Locations: 86
Primary Endpoint: All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
Status: Active, Not Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2012

End Date

November 1, 2026

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

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);

Outcomes

Primary Outcomes

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

Time Frame: 24 months

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 Outcomes

Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Percentage of Participants With Individual MACCE Components(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Percentage of Participants With Major Adverse Events (MAE)(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation(30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Change in Distance Walked During 6-minute Walk Test (6MWT)(From baseline to 30 days, baseline to 12 months, and baseline to 24 months)
Ratio of Days Alive Out of Hospital Versus Total Days Alive(12 and 24 months)
Quality of Life (QoL) Change From Baseline(Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Change in NYHA Class From Baseline(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.)
Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance(discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete)
Effective Orifice Area as an Assessment of Prosthetic Valve Performance(discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete)
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance(discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete)
Percentage of Participants With Aortic Valve Disease Related Hospitalizations(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete)
Percentage of Participants With Stroke and TIAs(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Peri-procedural Neurological Injury(discharge or 7 days post index procedure (whichever occurred first))
Index Procedure Related Major Adverse Events (MAEs)(Procedure through 30 day visit)
Length of Index Procedure Hospital Stay(Number of days from admission to discharge (expected average of 7 days))
Presence of Atrial Fibrillation(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.)
Device Success (Medtronic CoreValve® System Subjects Only)(Number of days from admission to discharge (expected average of 7 days))
Procedural Success (Medtronic CoreValve® System Subjects Only)(Number of days from admission to discharge (expected average of 7 days))
Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)(6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
Percentage of Participants With Early Safety Endpoint(30 Days)
Percentage of Participants With Clinical Efficacy (After 30 Days)(6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete)
Percentage of Participants With Time-Related Safety(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.)
Resheath and Recapture Success (Evolut R Only)(Procedure)