Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)

NCT02746809 | Completed Results DMC

• 1 other identifier: 10211838DOC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 10

Brief Summary

The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With All-cause Mortality

  Percentage of participants with all-cause mortality at 30 days

  30 Days

• Percentage of Participants With Stroke (Disabling)

  Percentage of participants with disabling stroke (VARC-II definitions) at 30 days

  30 Days

• Device Success Rate

  Device Success defined as: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Intended performance of the prosthetic heart valve, defined as the absence of patient prosthesis-mismatch and mean gradient \< 20 mmHg (or peak velocity \< 3 m/sec), AND * Absence of moderate or severe prosthetic valve regurgitation

  24 hours to 7 days post implantation

• The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram

  The percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory

  24 hours to 7 days post implantation

Secondary Outcomes (11)

• Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days

  30 days post-implantation

• Percentage of Participants With Life Threatening or Disabling Bleeding

  30 days post-implantation

• Percentage of Participants With Major Vascular Complication

  30 days

• Percentage of Participants With Acute Kidney Injury: Stage 2 or 3

  30 days

• Percentage of Participants With Coronary Artery Obstruction

  30 days

Study Arms (1)

CoreValve Evolut 34R TAVR system

EXPERIMENTAL

Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.

Device: CoreValve Evolut 34R TAVR system

Interventions

CoreValve Evolut 34R TAVR system DEVICE

The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components: 1. Evolut 34R Transcatheter Aortic Valve (TAV) 2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath 3. EnVeo R Loading System (LS)

CoreValve Evolut 34R TAVR system

Eligibility Criteria

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

You may qualify if:

• Severe aortic stenosis, defined as aortic valve area of \< 1.0 cm2 (or aortic valve area index of \< 0.6 cm2/m2) by the continuity equation, AND mean gradient \> 40 mmHg or maximal aortic valve velocity \> 4.0 m/sec by resting echocardiogram.
• 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 \< 1.0 cm2 (or aortic valve area index of \< 0.6 cm2/m2).
• Society of Thoracic Surgeons (STS) score of ≥ 8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities.
• Symptoms of aortic stenosis, AND New York Heart Association (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 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).

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (10)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

New York Langone Medical Center

New York, New York, 10016, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Pinnacle Health/Moffitt Heart and Vascular Institute

Harrisburg, Pennsylvania, 17104, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75225, United States

Location

Aurora Health Care/St Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

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: Phuong-Uyen Le
• Organization: Medtronic

phuong-uyen.n.le@medtronic.com

763-526-0989

Study Officials

• Mathew R Williams, MD

  NYU 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: April 18, 2016
• First Posted: April 21, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 15, 2021
• Last Updated: May 3, 2023
• Results First Posted: December 29, 2017

Record last verified: 2023-04

Locations

US (10)