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Stenoses, Aortic ValveNCT03084510

REPRISE China - Clinical Evaluation in China

A study testing Lotus Edge™ Valve System in people with Stenoses, Aortic Valve, run by Boston Scientific Corporation at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Stenoses, Aortic Valve
What is being tested?
Lotus Edge™ Valve System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
28 Feb 2020to 30 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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-
Show all 22Show fewer
  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cardiovascular Institute and Fu Wai Hospital

    Beijing

Other trials in China

About this study

Official title: REPRISE China: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Edge™ Valve System - Clinical Evaluation in China

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.

Read the 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.
Being tested
Lotus Edge™ Valve System
Keywords
High risk for surgical valve replacement, transcatheter aortic valve replacement
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lotus Edge™ Valve SystemDevice

    • 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.
Study groups in NCT03084510
Study groupRoleWhat they receive
Lotus Edge™ Valve SystemExperimentalThe 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.
Receives: Device: Lotus Edge™ Valve System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    All-cause mortality through 30 days post index procedure.

    Measured: Through 30 days post index procedure

  2. Mean aortic valve pressure gradient

    Mean aortic valve pressure gradient at 30 days post index procedure.

    Measured: At 30 days post index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2017
  2. Study start28 Feb 2020
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Why it stopped: study device was recalled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03084510
Sponsor's protocol ID
S6071
Status last verified
Nov 2023
First submitted
19 Oct 2016
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vahanian A, Baumgartner H, Bax J, Butchart E, Dion R, Filippatos G, Flachskampf F, Hall R, Iung B, Kasprzak J, Nataf P, Tornos P, Torracca L, Wenink A; Task Force on the Management of Valvular Hearth Disease of the European Society of Cardiology; ESC Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 2007 Jan;28(2):230-68. doi: 10.1093/eurheartj/ehl428. Epub 2007 Jan 26. No abstract available.

    PubMed 17259184

  • Thourani VH, Myung R, Kilgo P, Thompson K, Puskas JD, Lattouf OM, Cooper WA, Vega JD, Chen EP, Guyton RA. Long-term outcomes after isolated aortic valve replacement in octogenarians: a modern perspective. Ann Thorac Surg. 2008 Nov;86(5):1458-64; discussion 1464-5. doi: 10.1016/j.athoracsur.2008.06.036.

    PubMed 19049731

  • Barreto-Filho JA, Wang Y, Dodson JA, Desai MM, Sugeng L, Geirsson A, Krumholz HM. Trends in aortic valve replacement for elderly patients in the United States, 1999-2011. JAMA. 2013 Nov 20;310(19):2078-85. doi: 10.1001/jama.2013.282437.

    PubMed 24240935

  • Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Barwolf C, Boersma E, Ravaud P, Vahanian A. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005 Dec;26(24):2714-20. doi: 10.1093/eurheartj/ehi471. Epub 2005 Sep 1.

    PubMed 16141261

  • Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006 Dec;82(6):2111-5. doi: 10.1016/j.athoracsur.2006.07.048.

    PubMed 17126120

  • Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

    PubMed 20961243

  • Ben-Dor I, Pichard AD, Gonzalez MA, Weissman G, Li Y, Goldstein SA, Okubagzi P, Syed AI, Maluenda G, Collins SD, Delhaye C, Wakabayashi K, Gaglia MA Jr, Torguson R, Xue Z, Satler LF, Suddath WO, Kent KM, Lindsay J, Waksman R. Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation. Circulation. 2010 Sep 14;122(11 Suppl):S37-42. doi: 10.1161/CIRCULATIONAHA.109.926873.

    PubMed 20837923

  • Hara H, Pedersen WR, Ladich E, Mooney M, Virmani R, Nakamura M, Feldman T, Schwartz RS. Percutaneous balloon aortic valvuloplasty revisited: time for a renaissance? Circulation. 2007 Mar 27;115(12):e334-8. doi: 10.1161/CIRCULATIONAHA.106.657098. No abstract available.

    PubMed 17389271

  • Dewey TM, Brown DL, Das TS, Ryan WH, Fowler JE, Hoffman SD, Prince SL, Herbert MA, Culica D, Mack MJ. High-risk patients referred for transcatheter aortic valve implantation: management and outcomes. Ann Thorac Surg. 2008 Nov;86(5):1450-6; discussion 1456-7. doi: 10.1016/j.athoracsur.2008.07.043.

    PubMed 19049730

  • Saia F, Marrozzini C, Dall'Ara G, Russo V, Martin-Suarez S, Savini C, Ortolani P, Palmerini T, Taglieri N, Bordoni B, Pilato E, Di Bartolomeo R, Branzi A, Marzocchi A. How many patients with severe symptomatic aortic stenosis excluded for cardiac surgery are eligible for transcatheter heart valve implantation? J Cardiovasc Med (Hagerstown). 2010 Oct;11(10):727-32. doi: 10.2459/JCM.0b013e328338940f.

    PubMed 20414120

  • Thomas M. The global experience with percutaneous aortic valve replacement. JACC Cardiovasc Interv. 2010 Nov;3(11):1103-9. doi: 10.1016/j.jcin.2010.10.001.

    PubMed 21087744

  • Bourantas CV, Farooq V, Onuma Y, Piazza N, Van Mieghem NM, Serruys PW. Transcatheter aortic valve implantation: new developments and upcoming clinical trials. EuroIntervention. 2012 Sep;8(5):617-27. doi: 10.4244/EIJV8I5A94.

    PubMed 22995089

  • Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993 Apr;21(5):1220-5. doi: 10.1016/0735-1097(93)90249-z.

    PubMed 8459080

  • Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.

    PubMed 16980116

  • 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.

    PubMed 21160056

Questions about this trial

What is this clinical trial studying?

A study testing Lotus Edge™ Valve System in people with Stenoses, Aortic Valve, run by Boston Scientific Corporation at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: Through 30 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03084510, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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