Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
NCT ID: NCT02202434
Last Updated: 2021-12-17
Study Results
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View full resultsBasic Information
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TERMINATED
NA
1425 participants
INTERVENTIONAL
2014-09-22
2021-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lotus Valve System - Randomized
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
CoreValve TAVR System - Randomized
Transcatheter aortic valve replacement (TAVR) with CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
Procedure: Transcatheter aortic valve replacement (TAVR)
Lotus Valve Sytem - Single-arm 21mm Cohort
Transcatheter aortic valve replacement (TAVR) with 21mm Lotus Valve System
Lotus Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
Lotus Valve System - Single-arm Continued Access Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
Lotus Valve System - Single-arm Roll-in Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
LOTUS Edge Valve System - Single-arm Edge Nested Registry
Transcatheter aortic valve replacement (TAVR) with 23mm, 25mm and 27mm LOTUS Edge Valve System.
LOTUS Edge Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
Interventions
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Lotus Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
Procedure: Transcatheter aortic valve replacement (TAVR)
LOTUS Edge Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
Eligibility Criteria
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Inclusion Criteria
2. Subject has a documented aortic annulus size of ≥18 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC\]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is ≥20 mm and ≤27 mm.
3. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II
4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following.
* Society of Thoracic Surgeons (STS) score ≥8% -OR-
* If STS \<8, subject has at least one of the following conditions: Hostile chest, porcelain aorta, severe pulmonary hypertension (\>60 mmHg), prior chest radiation therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung disease (need for supplemental oxygen, forced expiratory volume in 1 second \[FEV1\] \<50% of predicted, diffusing capacity of the lungs for carbon monoxide \[DLCO\] \<60%, or other evidence of severe pulmonary dysfunction), neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement, orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement, Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial), frailty as indicated by at least one of the following: 5-meter walk \>6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body mass index \<21, wheelchair bound, unable to live independently, age ≥90 years, other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition)
5. Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
6. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
7. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).
Exclusion Criteria
2. Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
4. Subject has end-stage renal disease or has glomerular filtration rate (GFR) \<20 (based on Cockcroft-Gault formula).
5. Subject has a pre-existing prosthetic aortic or mitral valve.
6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
7. Subject has a need for emergency surgery for any reason.
8. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
9. Subject has echocardiographic evidence of new intra-cardiac mass, vegetation or intraventricular or paravalvular thrombus requiring intervention.
10. Subject has (hemoglobin) Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3.
11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
15. Subject has hypertrophic obstructive cardiomyopathy.
16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker implantation, which are allowed).
17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
18. Subject has severe left ventricular dysfunction with ejection fraction \<20%.
19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
20. Subject has severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid or vertebral disease).
21. Subject has thick (\>5 mm) protruding or ulcerated atheroma in the aortic arch
22. Subject has arterial access that is not acceptable for the test and control device delivery systems as defined in the device Instructions For Use.
23. Subject has current problems with substance abuse (e.g., alcohol, etc.).
24. Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
25. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
26. Subject has severe incapacitating dementia.
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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David Rizik, MD
Role: PRINCIPAL_INVESTIGATOR
Scottsdale Healthcare - Shea
Michael J Reardon, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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Banner Good Samaritan
Phoenix, Arizona, United States
Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
Scripps Clinic
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Veteran's Administration Palo Alto Medical Center
Palo Alto, California, United States
University of California at Davis Medical Center
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant Mease Healthcare System
Clearwater, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Evanston Hospital
Evanston, Illinois, United States
St. John's Hospital - Prairie Cardiovascular Consultants
Springfield, Illinois, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital
Petoskey, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Abbott Northwestern Hospital - Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine - Barnes Jewish Medical Center
St Louis, Missouri, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Kaleida Health
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
NC Heart and Vascular Research - Rex Hospital
Raleigh, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Ohio Health Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Methodist DeBakey Heart & Vascular Center
Houston, Texas, United States
Methodist Heart Hospital
San Antonio, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Providence Health - St. Paul's Hospital
Vancouver, British Columbia, Canada
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada
Clinique Pasteur
Toulouse, Midi-Pyrenees, France
Centre Hôpital Universitaire Rangueil
Toulouse, , France
Herzzentrum Universität Leipzig
Leipzig, Saxony, Germany
Universitares Herzzentrum UKE (Hamburg)
Hamburg, , Germany
Erasmus MC - University Medical Center Rotterdam
Rotterdam, , Netherlands
Countries
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References
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Rizik DG, Rajagopal V, Makkar RR, Bajwa T, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Iyer VS, Buchbinder M, Gotberg M, Bjursten H, Allocco DJ, Reardon MJ. Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238792. doi: 10.1001/jamanetworkopen.2022.38792.
Goel K, O'Leary JM, Barker CM, Levack M, Rajagopal V, Makkar RR, Bajwa T, Kleiman N, Linke A, Kereiakes DJ, Waksman R, Allocco DJ, Rizik DG, Reardon MJ, Lindman BR. Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2020 Sep;9(17):e017075. doi: 10.1161/JAHA.120.017075. Epub 2020 Aug 28.
Meduri CU, Kereiakes DJ, Rajagopal V, Makkar RR, O'Hair D, Linke A, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Schindler J, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ. Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. J Am Heart Assoc. 2019 Nov 5;8(21):e012594. doi: 10.1161/JAHA.119.012594. Epub 2019 Oct 23.
Reardon MJ, Feldman TE, Meduri CU, Makkar RR, O'Hair D, Linke A, Kereiakes DJ, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchetche D, Rovin JD, Lhermusier T, Carrie D, Hodson RW, Allocco DJ, Meredith IT; Reprise III Investigators. Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):223-229. doi: 10.1001/jamacardio.2019.0091.
Asch FM, Vannan MA, Singh S, Khandheria B, Little SH, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ, Weissman NJ. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. Circulation. 2018 Jun 12;137(24):2557-2567. doi: 10.1161/CIRCULATIONAHA.118.034129. Epub 2018 Mar 12.
Feldman TE, Reardon MJ, Rajagopal V, Makkar RR, Bajwa TK, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchetche D, Rovin JD, Buchbinder M, Meredith IT, Gotberg M, Bjursten H, Meduri C, Salinger MH, Allocco DJ, Dawkins KD. Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial. JAMA. 2018 Jan 2;319(1):27-37. doi: 10.1001/jama.2017.19132.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S2282
Identifier Type: -
Identifier Source: org_study_id