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Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

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ClinicalTrials.gov Identifier: NCT02701283
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Brief Summary:

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Medtronic Transcatheter Aortic Valve Replacement Systems Device: Surgical Aortic Valve Replacement (SAVR) Not Applicable

Detailed Description:

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
Study Start Date : March 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medtronic Transcatheter Aortic Valve Replacement Systems
Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Device: Medtronic Transcatheter Aortic Valve Replacement Systems
Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

Active Comparator: Surgical Aortic Valve Replacement (SAVR)
Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)
Device: Surgical Aortic Valve Replacement (SAVR)
Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis




Primary Outcome Measures :
  1. All-cause mortality or disabling stroke [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Composite of death, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) [ Time Frame: 30 days ]
  2. Number of patients with new permanent pacemaker implantation [ Time Frame: 30 days ]
  3. Number of patients with prosthetic valve endocarditis per the Duke criteria [ Time Frame: 1 year ]
  4. Prosthetic valve thrombosis [ Time Frame: 1 year ]
  5. All stroke (disabling and non-disabling) [ Time Frame: 1 year ]
  6. Number of patients with life-threatening bleed [ Time Frame: 1 year ]
  7. Number of patients with valve-related dysfunction requiring repeat procedure [ Time Frame: 1 year ]
  8. Number of patients with valve-related dysfunction (moderate or severe stenosis or regurgitation) [ Time Frame: 1 year ]
  9. Quality of Life as assessed by Kansas City Cardiomyopathy (KCCQ) [ Time Frame: 30 days and 1 year ]
  10. Number of patients with repeat hospitalization for signs and symptoms of aortic valve disease [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Health related quality of life assessed by EQ-5D Survey Instrument [ Time Frame: 1 year ]
    The EQ-5D was developed by the Euro-Qol Group and is a survey instrument designed to measure quality of life across 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). The survey is comprised of a descriptive system and a visual analogue scale where subjects rate their current state of health.

  2. New York Heart Association (NYHA) functional classification [ Time Frame: 1 year ]
  3. Hemodynamic performance as measured by mean aortic gradient at one year by Doppler echocardiography [ Time Frame: 1 year ]
  4. Device success (VARC II) [ Time Frame: 30 days and through annual visits to 10 years ]
    The VARC II definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mm Hg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation

  5. Hemodynamic performance as measured by effective orifice area at one year by Doppler echocardiography [ Time Frame: 1 year ]
  6. Hemodynamic performance as measured by degree of total, peri, and transvalvular prosthetic regurgitation at one year by Doppler echocardiography [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe aortic stenosis, defined as follows:

    1. For symptomatic patients:

      Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

    2. For asymptomatic patients:

      • Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
  2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
  3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

  1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
  2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

    1. aspirin or heparin (HIT/HITTS) and bivalirudin
    2. ticlopidine and clopidogrel
    3. Nitinol (titanium or nickel)
    4. contrast media
  3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  4. Ongoing sepsis, including active endocarditis.
  5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
  6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
  7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
  8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  11. Subject refuses a blood transfusion.
  12. 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).
  13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
  14. 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.
  15. Currently participating in an investigational drug or another device trial (excluding registries).
  16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
  17. Need for emergency surgery for any reason.
  18. Subject is pregnant or breast feeding.
  19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
  20. Pre-existing prosthetic heart valve in any position.
  21. Severe mitral regurgitation amenable to surgical replacement or repair.
  22. Severe tricuspid regurgitation amenable to surgical replacement or repair.
  23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
  24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
  25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
  26. Prohibitive left ventricular outflow tract calcification.
  27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
  28. Aortic annulus diameter of <18 or >30 mm.
  29. Significant aortopathy requiring ascending aortic replacement.

    For transfemoral or transaxillary (subclavian) access:

  30. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701283


Contacts
Contact: Joleen Perkins 1-763-514-9731 joleen.perkins@medtronic.com
Contact: Jennifer Maloney +17635058644 jennifer.s.maloney@medtronic.com

  Hide Study Locations
Locations
United States, Arizona
Abrazo Arizona Heart Hospital Active, not recruiting
Phoenix, Arizona, United States, 85016
United States, California
Scripps Memorial Hospital La Jolla Active, not recruiting
La Jolla, California, United States, 92037
University of Southern California University Hospital Active, not recruiting
Los Angeles, California, United States, 90033
El Camino Hospital Active, not recruiting
Mountain View, California, United States, 64040
Mercy General Hospital Active, not recruiting
Sacramento, California, United States, 95816
Los Robles Hospital & Medical Center Active, not recruiting
Thousand Oaks, California, United States, 91360
United States, Colorado
University of Colorado Hospital Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale New Haven Hospital Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Morton Plant Hospital Active, not recruiting
Clearwater, Florida, United States, 33756
Delray Medical Center Active, not recruiting
Delray Beach, Florida, United States, 33484
HealthPark Medical Center Active, not recruiting
Fort Myers, Florida, United States, 33908
University of Miami Hospital Active, not recruiting
Miami, Florida, United States, 33136
Tallahassee Research Institute, Inc. Active, not recruiting
Tallahassee, Florida, United States, 32308
United States, Georgia
Piedmont Atlanta Hospital Active, not recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
Loyola University Medical Center Active, not recruiting
Maywood, Illinois, United States, 60153
United States, Indiana
Saint Vincent Heart Center of Indiana Active, not recruiting
Indianapolis, Indiana, United States, 46290
United States, Iowa
Mercy Medical Center Active, not recruiting
Des Moines, Iowa, United States, 50314
United States, Kansas
The University of Kansas Hospital Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Jewish Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Terrebonne General Medical Center Active, not recruiting
Houma, Louisiana, United States, 70360
United States, Maryland
University of Maryland Medical Center Active, not recruiting
Baltimore, Maryland, United States, 21201
MedStar Union Memorial Hospital Active, not recruiting
Baltimore, Maryland, United States, 21218
The Johns Hopkins Hospital Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02215
Baystate Medical Center Active, not recruiting
Springfield, Massachusetts, United States, 01199
United States, Michigan
University of Michigan Health System Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Saint John Hospital and Medical Center Active, not recruiting
Detroit, Michigan, United States, 48236
Spectrum Health Hospitals Active, not recruiting
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Abbott Northwestern Hospital Active, not recruiting
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Mercy Hospital Active, not recruiting
Springfield, Missouri, United States, 65806
United States, New York
Saint Francis Hospital Active, not recruiting
East Hills, New York, United States, 11548
Saint Joseph's Hospital Health Center Active, not recruiting
Liverpool, New York, United States, 13088
Northwell Health Active, not recruiting
Manhasset, New York, United States, 11030
The Mount Sinai Hospital Active, not recruiting
New York, New York, United States, 10029
Strong Memorial Hospital Active, not recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
Wake Forest Baptist Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Medical Center Active, not recruiting
Fargo, North Dakota, United States, 58122
United States, Ohio
Good Samaritan Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45220
University Hospitals Case Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University Active, not recruiting
Columbus, Ohio, United States, 43210
OhioHealth Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
United States, Oklahoma
Integris Baptist Medical Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Oregon Health Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital Active, not recruiting
Allentown, Pennsylvania, United States, 18103
Geinsinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17043
Pinnacle Health Active, not recruiting
Harrisburg, Pennsylvania, United States, 17043
University of Pittsburgh Medical Center UPMC Presbyterian Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Active, not recruiting
Dallas, Texas, United States, 75204
Baylor Saint Luke's Medical Center Active, not recruiting
Houston, Texas, United States, 77030
Houston Methodist Hospital Active, not recruiting
Houston, Texas, United States, 77030
Methodist Hospital San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Utah
University Hospital Salt Lake City Utah Active, not recruiting
Salt Lake City, Utah, United States, 84132
United States, Vermont
The University of Vermont Medical Center Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Saint Mary's Hospital Active, not recruiting
Richmond, Virginia, United States, 23226
Winchester Medical Center Active, not recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98124
United States, Wisconsin
Aurora Saint Luke's Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
Royal North Shore Hospital Active, not recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Monash Health Monash Heart Active, not recruiting
Clayton, Victoria, Australia, 3168
The Alfred Hospital Active, not recruiting
Melbourne, Victoria, Australia, 3004
Australia
Saint Vincent's Hospital (SVH) Active, not recruiting
Darlinghurst, Australia, 2010
The Alfred Hospital Active, not recruiting
Melbourne, Australia
Fiona Stanley Hospital (FSH) Active, not recruiting
Murdoch, Australia, 6150
Canada, Ontario
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 5A5
Toronto General Health Hospital Active, not recruiting
Toronto, Ontario, Canada, MSG2C4
Canada, Quebec
Glen Royal Victoria (McGill) Active, not recruiting
Montréal, Quebec, Canada, H4A 3J1
Canada
Montreal Heart Active, not recruiting
Montréal, Canada, H1T 1C8
IUCPQ Active, not recruiting
Quebec, Canada, G1V 4G5
Sunnybrook Health Sciences Centre Active, not recruiting
Toronto, Canada
France
Centre Hospitalier Régional Universitaire de Lille Active, not recruiting
Lille, France, 59000
L'Hôpital Privé Jacques Cartier Massy Active, not recruiting
Massy, France
Clinique Pasteur Active, not recruiting
Toulouse, France, 31300
Japan
Kokura Memorial Hospital Recruiting
Kitakyushu, Fokuoka, Japan
Principal Investigator: Kenji Ando         
Sapporo Higashi Tokushukai Hospital Recruiting
Sapporo, Hokkaido, Japan
Principal Investigator: Seiji Yamazaki         
Teikyo University Hospital Recruiting
Tokyo, Itabashi-K, Japan
Principal Investigator: Ken Kozuma         
Shonan Kamakura General Hospital Recruiting
Kamakura, Kanagawa, Japan
Principal Investigator: Shigeru Saito         
Sendai Kousei Hospital Recruiting
Sendai, Miyagi, Japan
Principal Investigator: Norio Tada         
National Cerebral and Cardiovasclular Center Recruiting
Suita, Osaka, Japan, 565-8565
Principal Investigator: Junjiro Kobayashi         
Osaka University Hospital Recruiting
Suita, Osaka, Japan
Principal Investigator: Yoshiki Sawa         
Sakakibara Heart Institute Recruiting
Fuchu, Tokyo, Japan
Principal Investigator: Tetsuya Tobaru         
Netherlands
Academic Medical Center Amsterdam Withdrawn
Amsterdam, Netherlands
Catharina Ziekenhuis Active, not recruiting
Eindhoven, Netherlands, 5623
St. Antonius Hospital Nieuwegein Active, not recruiting
Nieuwegein, Netherlands
Erasmus Medisch Centrum Active, not recruiting
Rotterdam, Netherlands, 3015
New Zealand
Waikato Hospital Active, not recruiting
Hamilton, New Zealand
Switzerland
UniversitätsSpital Zürich Active, not recruiting
Zürich, Switzerland
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: Jeffrey Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: Michael Reardon, MD The Methodist Hospital System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT02701283     History of Changes
Other Study ID Numbers: 10234430Doc
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction