REPRISE China - Clinical Evaluation in China

NCT03084510 | Withdrawn

• 1 other identifier: S6071
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenoses, Aortic Valve

Keywords

High risk for surgical valve replacement; transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  All-cause mortality through 30 days post index procedure.

  Through 30 days post index procedure

• Mean aortic valve pressure gradient

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

  At 30 days post index procedure

Other Outcomes (6)

• Safety endpoints adjudicated by an independent Clinical Events Committee (CEC)

  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 Performance

  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

• Procedural success

  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

Study Arms (1)

Lotus Edge™ Valve System

EXPERIMENTAL

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

Interventions

Lotus Edge™ Valve System DEVICE

• 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.

Lotus Edge™ Valve System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Cardiovascular Institute and Fu Wai Hospital

Beijing, China

Location

Related Publications (20)

• 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.

  PMID: 17259184 BACKGROUND

• 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.

  PMID: 19049731 BACKGROUND

• 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.

  PMID: 24240935 BACKGROUND

• 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.

  PMID: 16141261 BACKGROUND

• 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.

  PMID: 17126120 BACKGROUND

• 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.

  PMID: 20961243 BACKGROUND

• 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.

  PMID: 20837923 BACKGROUND

• 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.

  PMID: 17389271 BACKGROUND

• 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.

  PMID: 19049730 BACKGROUND

• 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.

  PMID: 20414120 BACKGROUND

• 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.

  PMID: 21087744 BACKGROUND

• 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.

  PMID: 22995089 BACKGROUND

• 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.

  PMID: 8459080 RESULT

• 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.

  PMID: 16980116 RESULT

• 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.

  PMID: 21160056 RESULT

• Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

  PMID: 12831818 RESULT

• Brown JM, O'Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg. 2009 Jan;137(1):82-90. doi: 10.1016/j.jtcvs.2008.08.015.

  PMID: 19154908 RESULT

• Chiam PT, Ruiz CE. Percutaneous transcatheter aortic valve implantation: Evolution of the technology. Am Heart J. 2009 Feb;157(2):229-42. doi: 10.1016/j.ahj.2008.10.003.

  PMID: 19185629 RESULT

• 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. doi: 10.1161/CIRCULATIONAHA.106.176857. No abstract available.

  PMID: 16880336 RESULT

• Holmes DR Jr, Mack MJ, Kaul S, Agnihotri A, Alexander KP, Bailey SR, Calhoon JH, Carabello BA, Desai MY, Edwards FH, Francis GS, Gardner TJ, Kappetein AP, Linderbaum JA, Mukherjee C, Mukherjee D, Otto CM, Ruiz CE, Sacco RL, Smith D, Thomas JD. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Mar 27;59(13):1200-54. doi: 10.1016/j.jacc.2012.01.001. Epub 2012 Jan 31. No abstract available.

  PMID: 22300974 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Runlin GAO, Doctor

  Cardiovascular Institute and Fu Wai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: March 21, 2017
• Study Start: February 28, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)