Medtronic CoreValve Evolut R U.S. Clinical Study

NCT02207569 | Completed Results DMC

• 1 other identifier: 10126779DOC
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 23

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (4)

• All-cause Mortality at 30 Days by Percent

  Percentage of patients that died by any cause at 30 days

  Assessed at 30 days post-implantation

• Percentage of Patients With Disabling Stroke at 30 Days

  Stroke Diagnostic Criteria: \> Acute episode of focal or global neurological deficit with at least 2 of the following: * change in level of consciousness \> * hemiplegia, hemiparesis * numbness or sensory loss affecting 1 side \> * dysphasia or aphasia * hemianopia * amaurosis fugax \> * other neurological signs or symptoms consistent with stroke 2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist 3.) Confirmation of the diagnosis by at least 1 of the following: * Neurological specialist \> * Neuroimaging procedure, or on clincial grounds alone \> Stroke: durations of neural deficit \> 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death Defined by VARC II: \> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline

  Assessed at 30 days post-implantation

• Percent Device Success Rate Between 24 and 7 Day

  Percentage of patients with Device Success defined as: * Absence of procedural mortality, AND * Correct positioning of a single Evolut R valve into the proper anatomical location, AND * Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity \< 3m/sec, AND * Absence of moderate or severe prosthetic valve regurgitation

  Assessed at 24 hours to seven days post implantation

• Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)

  Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.

  Assessed at 24 hours to 7 days post implantation

Secondary Outcomes (11)

• Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)

  Assessed at 30 days post-implantation

• Coronary Artery Obstruction Requiring Intervention.

  Assessed at 30 days post-implantation

• Percent VARC II Combined Safety Endpoint at 30 Days

  Assessed at 30 days post-implantation

• Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).

  Assessed at 30 days post-implantation

• Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate

  Assessed at 30 days post-implantation

Study Arms (1)

CoreValve Evolut R TAVR system

EXPERIMENTAL

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)

Device: CoreValve Evolut R TAVR system

Interventions

CoreValve Evolut R TAVR system DEVICE

CoreValve Evolut R TAVR system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (23)

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Washington Hospital Center/Medstar

Washington D.C., District of Columbia, 20010, United States

Location

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

Indianapolis, Indiana, 46290, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconcess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Detroit Medical Center Cardiovascular Institute

Detroit, Michigan, 48201, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

New York Langone Medical Center

New York, New York, 10016, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Riverside Methodist Hospital/Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Pinnacle Health

Wormleysburg, Pennsylvania, 17043, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75225, United States

Location

The Methodist DeBakey Heart & Vasc Ctr/The Methodist Hosp

Houston, Texas, 77030, United States

Location

Aurora Health Care/St Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• 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.

  PMID: 28183466 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Kristin Smith
• Organization: Medtronic

kristin.m.smith@medtronic.com

763-526-3095

Study Officials

• Mathew R Williams, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: August 4, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: October 28, 2020
• Last Updated: November 2, 2022
• Results First Posted: December 12, 2017

Record last verified: 2022-10

Locations

US (23)