REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects

NCT03618095 | Terminated Results DMC FDA Device

• 1 other identifier: S2354
• Study Type: interventional
• Target: 382
• Locations: 2 countries
• Sites: 50

Brief Summary

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

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Main Cohort

EXPERIMENTAL

Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System

Device: LOTUS Edge Valve System

Roll-In Cohort

EXPERIMENTAL

Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System

Device: LOTUS Edge Valve System

Bicuspid Cohort

EXPERIMENTAL

Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System

Device: LOTUS Edge Valve System

Interventions

LOTUS Edge Valve System DEVICE

TAVR with the LOTUS Edge Valve System

Bicuspid Cohort; Main Cohort; Roll-In Cohort

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the Bicuspid Nested Registry 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (50)

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Mills-Peninsula Medical Center - Sutter Health

Burlingame, California, 94010, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

USC Medical Center

Los Angeles, California, 90033, United States

Location

Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Medstar Heart and Vascular Institute

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

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Wellstar Research Institute

Marietta, Georgia, 30060, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Indiana University Health - Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Via Christi Hospital

Wichita, Kansas, 67214, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Charlton Memorial Hospital - Southcoast Health

Fall River, Massachusetts, 02720, United States

Location

Spectrum Health - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

Englewood Hospital

Englewood, New Jersey, 07631, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

NYU Langone Medical Center

New York, New York, 10010, United States

Location

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

Novant Health Heart & Vascular Institute - Charlotte

Charlotte, North Carolina, 28204, United States

Location

UNC Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

The Lindner Center for Research and Education

Cincinnati, Ohio, 45219, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Greenville Memorial Hospital - Prisma Health

Greenville, South Carolina, 29605, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Memorial Hermann - Texas Medical Center

Houston, Texas, 77030, United States

Location

University of Texas - Memorial Hermann Southwest

Houston, Texas, 77030, United States

Location

Baylor Scott & White The Heart Hospital

Plano, Texas, 75093, United States

Location

Inova Fairfax Hospital

Annandale, Virginia, 22042, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

WVU Heart & Vascular Institute

Morgantown, West Virginia, 26506, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Froedtert Hospital - Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Monash Cardiovascular Research Centre

Clayton, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated during enrollment and all follow-up of patients was also discontinued. As a result, the primary outcome is not representative of the full cohort of patients and represents a significantly smaller sample of patients to reach the 1 year timepoint in the Main cohort.

Results Point of Contact

• Title: Amy Maurer
• Organization: Boston Scientific

amy.maurer@bsci.com

800-876-9960

Study Officials

• Christopher U. Meduri, MD, MPH

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

• Vinod H. Thourani, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: Evaluation of Lotus Edge to treat patients with aortic stenosis. A single intervention is being evaluated in 3 study arms, the roll-in, main and bicuspid cohorts.

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: January 14, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 31, 2021
• Last Updated: December 27, 2022
• Results First Posted: December 27, 2022

Record last verified: 2022-10

Locations

AU (1); US (49)