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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03618095
Other study ID # S2354
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 14, 2019
Est. completion date March 31, 2021

Study information

Verified date October 2022
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects


Description:

To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.


Recruitment information / eligibility

Status Terminated
Enrollment 382
Est. completion date March 31, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject has documented severe aortic stenosis defined as initial aortic valve area (AVA) =1.0 cm2 (or AVA index =0.6 cm2/m2) AND a mean pressure gradient =40 mm Hg OR maximal aortic valve velocity =4.0 m/s OR Doppler velocity index =0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended)c; the subject may be enrolled if echocardiographic criteria are met with this augmentation. (IC1) - A subject in the Bicuspid Aortic Valve Nested Registry cohort must have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on computed tomography (CT) assessment and confirmed by the CT core lab with hemodynamic parameters that meet the criteria in IC1. - Subject has a documented aortic annulus size of =20 mm and =27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]). - Subject has symptomatic aortic valve stenosis per IC1 definition above with New York Heart Association (NYHA) Functional Class = II. - Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is at intermediate risk of operative mortality (=3% and <8% at 30 days based on the Society of Thoracic Surgeons [STS] risk score and other clinical comorbidities unmeasured by the risk calculator) and TAVR is appropriate. Note: Risk of operative mortality 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). - Heart team agrees that the subject is likely to benefit from valve replacement. IC7. Subject (or legal representative) has been informed of the study requirements and the treatment procedures, and provides written informed consent. - 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. - Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy. Exclusion Criteria: - Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the Bicuspid Nested Registry cohort). - Subjects in the Bicuspid Nested Registry cohort will have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab. Subjects are not eligible for inclusion in the Bicuspid Nested Registry cohort if the maximum diameter of the ascending aorta is >45 mm or if the subject has another indication for aortic root replacement. Subjects with a Sievers Type 2 bicuspid valve are not eligible for enrollment in any study cohort. - 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). - Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment. - Subject is on renal replacement therapy or has Glomerular Filtration Rate (GFR) <20 (based on hospital preferred method). See AEC1 below if subject is in the CT Imaging Substudy. - Subject has a pre-existing prosthetic aortic or mitral valve. - Subject has severe (4+) aortic, tricuspid, or mitral regurgitation. - Subject has moderate to severe mitral stenosis (mitral valve area =1.5 cm2 and diastolic pressure half-time =150 ms, Stage C or Dc). - Subject has a need for emergency surgery for any reason. - Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis. - Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention. - Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3. - Subject will refuse transfusions or 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. - 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. - Subject has a life expectancy of less than 24 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment. - Subject has hypertrophic cardiomyopathy. - Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker or implantable cardioverter defibrillator implantation, which are allowed). - Subject has multivessel coronary artery disease with a Syntax score >22, and/or an unprotected left main coronary artery. - Subject has severe left ventricular dysfunction with ejection fraction <20%. - Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices. - Subject has arterial access that is not acceptable for the study device delivery system as defined in the device Instructions For Use. - 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 thick, protruding, ulcerated atheroma in the aortic arch). - Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study. - Subject is participating in another investigational drug or device study that has not reached its primary endpoint. - 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. - Subject has severe incapacitating dementia.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
LOTUS Edge Valve System
TAVR with the LOTUS Edge Valve System

Locations

Country Name City State
Australia Monash Cardiovascular Research Centre Clayton Victoria
United States Inova Fairfax Hospital Annandale Virginia
United States Piedmont Heart Institute Atlanta Georgia
United States JFK Medical Center Atlantis Florida
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Mills-Peninsula Medical Center - Sutter Health Burlingame California
United States Novant Health Heart & Vascular Institute - Charlotte Charlotte North Carolina
United States The Lindner Center for Research and Education Cincinnati Ohio
United States Saint Joseph Hospital Denver Colorado
United States Englewood Hospital Englewood New Jersey
United States NorthShore University HealthSystem Evanston Illinois
United States Charlton Memorial Hospital - Southcoast Health Fall River Massachusetts
United States North Florida Regional Medical Center Gainesville Florida
United States Spectrum Health - Grand Rapids Grand Rapids Michigan
United States Greenville Memorial Hospital - Prisma Health Greenville South Carolina
United States Memorial Hermann - Texas Medical Center Houston Texas
United States University of Texas - Memorial Hermann Southwest Houston Texas
United States Huntsville Hospital Huntsville Alabama
United States Indiana University Health - Methodist Hospital Indianapolis Indiana
United States Arkansas Heart Hospital Little Rock Arkansas
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States USC Medical Center Los Angeles California
United States North Shore University Hospital Manhasset New York
United States Wellstar Research Institute Marietta Georgia
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States Froedtert Hospital - Medical College of Wisconsin Milwaukee Wisconsin
United States NYU Winthrop Hospital Mineola New York
United States WVU Heart & Vascular Institute Morgantown West Virginia
United States Morristown Medical Center Morristown New Jersey
United States Centennial Medical Center Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Ochsner Medical Center New Orleans Louisiana
United States Columbia University Medical Center/NewYork Presbyterian Hospital New York New York
United States NYU Langone Medical Center New York New York
United States AdventHealth Orlando Orlando Florida
United States Cardiac & Vascular Research Center of Northern Michigan Petoskey Michigan
United States University of Pennsylvania Philadelphia Pennsylvania
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Baylor Scott & White The Heart Hospital Plano Texas
United States Providence St. Vincent Medical Center Portland Oregon
United States UNC Rex Hospital Raleigh North Carolina
United States Beaumont Hospital Royal Oak Michigan
United States St. Cloud Hospital Saint Cloud Minnesota
United States Swedish Medical Center Seattle Washington
United States University of Washington Seattle Washington
United States Tucson Medical Center Tucson Arizona
United States Medstar Heart and Vascular Institute Washington District of Columbia
United States Via Christi Hospital Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of All-cause Mortality and All Stroke. Pre-specified primary outcome measure in the protocol for the Main Cohort only. Critical safety events that are observed in the elderly population undergoing TAVR; assessments recommended by Valve Academic Research Consortium (VARC) 1 year post index procedure and device implantation
See also
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Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
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Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease