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REPRISE China - Clinical Evaluation in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084510
Recruitment Status : Withdrawn (study device was recalled.)
First Posted : March 21, 2017
Last Update Posted : December 30, 2020
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic stenosis who are considered at high risk for surgical valve replacement.

Condition or disease Intervention/treatment Phase
Stenoses, Aortic Valve Device: Lotus Edge™ Valve System Not Applicable

Detailed Description:
  1. A independent Clinical Events Committee (CEC) will adjudge the safety endpoint.
  2. 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]).
  3. Monitor will review the source data regularly to compare the EDC to ensure the data entry can be accuracy, completeness, or representativeness.
  4. Will recruit maximum 62 subjects in maximum 6 sites
  5. Boston Scientific's Standard Operating Procedures to address operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REPRISE China: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Edge™ Valve System - Clinical Evaluation in China
Actual Study Start Date : February 28, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lotus Edge™ Valve System
The Lotus Edge™ Valve System is intended to improve the aortic valve function for symptomatic patients with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Device: Lotus Edge™ Valve System

• The Lotus Edge™ Valve System consisting of two main components:

  • a bioprosthetic bovine pericardial aortic valve, and
  • a delivery system Device sizes include 23 mm, 25 mm and 27 mm diameter.




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Through 30 days post index procedure ]
    All-cause mortality through 30 days post index procedure.

  2. Mean aortic valve pressure gradient [ Time Frame: At 30 days post index procedure ]
    Mean aortic valve pressure gradient at 30 days post index procedure.


Other Outcome Measures:
  1. Safety endpoints adjudicated by an independent Clinical Events Committee (CEC) [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]
    Mortality: all-cause, cardiovascular, and non-cardiovascular Stroke: disabling and non-disabling Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure) Bleeding: life-threatening (or disabling) and major Acute kidney injury (≤7 days post index procedure): based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2 Major vascular complication Repeat procedure for valve-related dysfunction (surgical or interventional therapy) Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)

  2. Device Performance [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]
    Successful vascular access, delivery and deployment of the study valve, and successful retrieval of the delivery system Successful retrieval of the study valve if retrieval is attempted Successful repositioning of the study valve if repositioning is attempted Grade of aortic valve regurgitation: paravalvular, central, and combined

  3. Procedural success [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]
    device and/or procedure related serious adverse events (SAEs) and death, correct positioning of a single transcatheter valve into the proper anatomical location, intended performance of the study device (effective orifice area [EOA] >0.9 cm2 for BSA <1.6 m2 and EOA >1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity <3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) at discharge or 7 days post-procedure (whichever comes first)

  4. prosthetic aortic valve performance as measured by transthoracic echocardiography (TTE) [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]
    assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation

  5. New York Heart Association (NYHA) [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]
    New York Heart Association (NYHA) functional classification

  6. Paravalvular aortic regurgitation [ Time Frame: At 30 days and 12 months ]
    Moderate or greater paravalvular aortic regurgitation (based on core lab assessment) at 30 days and 12 months



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.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 70 years.
  • Subject has documented calcific, severe native aortic stenosis with an initial AVA of <1.0 cm2 (or AVA index of <0.6 cm2/m2), and a mean pressure gradient ≥40 mm Hg or jet velocity ≥4.0 m/s or doppler velocity index ≤0.25, as measured by echocardiography and/or invasive hemodynamics.
  • 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 with NYHA Functional Class ≥ II.
  • 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 operative risk for surgical valve replacement (see note below for definition of 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, FEV1 < 50% of predicted, 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 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 risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high risk definition)
  • Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
  • Subject (or legal representative) understands 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.

Exclusion Criteria:

  • Subject has a congenital unicuspid aortic valve or Sievers Type 2 bicuspid aortic valve.
  • Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
  • Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
  • Subject has end-stage renal disease or has serum creatinine > 3mg/dl or has creatinine clearance rate <45ml/min.
  • Subject has a pre-existing prosthetic aortic or mitral valve.
  • Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
  • 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 (50×109/L) or > 700,000 cells/mm3 (700×109/L), or white blood cell count < 1,000 cells/mm3 (1×109/L).
  • 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.
  • 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
  • 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 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment
  • Subject has hypertrophic obstructive 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 implantation, which is allowed)
  • Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization
  • 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 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)
  • Subject has thick (> 5 mm) protruding or ulcerated atheroma in the aortic arch
  • Subject has an enlarged ascending aorta with the diameter > 50mm
  • Subject has arterial access that is not acceptable for the study device delivery system as defined in the device Instructions For Use
  • Subject has current problems with substance abuse (e.g., alcohol, etc.)
  • 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

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): NCT03084510


Locations
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China
Cardiovascular Institute and Fu Wai Hospital
Beijing, China
Sponsors and Collaborators
Boston Scientific Corporation
Quintiles, Inc.
Investigators
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Study Chair: Zhiyu Zeng, Doctor BSC
Publications of Results:
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. Erratum in: Circulation. 2011 Feb 15;123(6):e240. Circulation. 2011 Oct 18;124(16):e426.
American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons, Bonow RO, Carabello BA, Kanu C, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Circulation. 2006 Aug 1;114(5):e84-231. Review. Erratum in: Circulation. 2007 Apr 17;115(15):e409. Circulation. 2010 Jun 15;121(23):e443.

Other Publications:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03084510    
Other Study ID Numbers: S6071
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Scientific Corporation:
High risk for surgical valve replacement
transcatheter aortic valve replacement
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction