Medtronic CoreValve Evolut R U.S. Clinical Study

NCT ID: NCT02207569

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2020-10-28

Brief Summary

The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.

Detailed Description

This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving a minimum of 150 implanted subjects with no more than 250 implanted subjects at up to 25 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation.

The enrollment phase of the study is estimated to take approximately 6-9 months. As each implanted subject is to be followed up to 5 years, the estimated study duration is approximately 66-69 months, excluding the time required for preparing the final report.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CoreValve Evolut R TAVR system

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

1. Evolut R Transcatheter Aortic Valve (TAV)

2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

3. EnVeo R Loading System (LS)

Group Type: EXPERIMENTAL

CoreValve Evolut R TAVR system

Intervention Type: DEVICE

Interventions

CoreValve Evolut R TAVR system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of >40 mmHg or a maximal aortic valve velocity of >4.0 m/sec, AND aortic valve area of <1.0cm2 (or aortic valve area index of <0.6 cm2/m2).

• STS score of ≥ 8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities.
• Symptoms of aortic stenosis, AND NYHA Functional Class II or greater
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria

• Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin (HIT/HITTS) and bivalirudin, ticlopidine and clopidogrel, Nitinol (titanium or nickel), contrast media
• Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
• End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
• Ongoing sepsis, including active endocarditis.
• Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to the study procedure.
• 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 6 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 study/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 12 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-ups exams.
• Currently participating in an investigational drug or another device study (excluding registries).
• Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
• Need for emergency surgery for any reason.
• Liver failure (Child-Pugh class C).
• Subject is pregnant or breast feeding.

• Pre-existing prosthetic heart valve in any position.
• Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
• Severe mitral regurgitation.
• Severe tricuspid regurgitation.
• Moderate or severe mitral stenosis.
• Hypertrophic obstructive cardiomyopathy.
• Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation.
• Congenital bicuspid or unicuspid valve verified by echocardiography.

For transfemoral or transaxillary (subclavian) acess:

• Access vessel diameter <5.0mm or <6.0mm for patent LIMA

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathew R Williams, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

University of Southern California

Los Angeles, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington Hospital Center/Medstar

Washington D.C., District of Columbia, United States

St. Vincent Heart Center of Indiana/The Care Group, LLC

Indianapolis, Indiana, United States

University of Kansas

Kansas City, Kansas, United States

The Johns Hopkins University

Baltimore, Maryland, United States

Beth Israel Deaconcess Medical Center

Boston, Massachusetts, United States

University of Michigan Health Systems

Ann Arbor, Michigan, United States

Detroit Medical Center Cardiovascular Institute

Detroit, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

New York Langone Medical Center

New York, New York, United States

The Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Riverside Methodist Hospital/Ohio Health Research Institute

Columbus, Ohio, United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, United States

Pinnacle Health

Wormleysburg, Pennsylvania, United States

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

The Methodist DeBakey Heart & Vasc Ctr/The Methodist Hosp

Houston, Texas, United States

Aurora Health Care/St Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Popma JJ, Reardon MJ, Khabbaz K, Harrison JK, Hughes GC, Kodali S, George I, Deeb GM, Chetcuti S, Kipperman R, Brown J, Qiao H, Slater J, Williams MR. Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study. JACC Cardiovasc Interv. 2017 Feb 13;10(3):268-275. doi: 10.1016/j.jcin.2016.08.050.

Reference Type: DERIVED

PMID: 28183466 (View on PubMed)

Other Identifiers

10126779DOC

Identifier Type: -

Identifier Source: org_study_id