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Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System

2. července 2019 aktualizováno: Boston Scientific Corporation

REPRISE II FLEX: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With a FLEXible Delivery System - Confirmation of Performance and Safety

To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Přehled studie

Postavení

Dokončeno

Detailní popis

This clinical study is a prospective, single-arm study designed to confirm that the acute performance and safety of the Lotus Valve Flex System for TAVR are consistent with the results of the Lotus Valve System in the REPRISE II study, when delivered and deployed in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).

Typ studie

Intervenční

Zápis (Aktuální)

4

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Queensland
      • Chermside, Queensland, Austrálie, 4032
        • Prince Charles Hospital
    • Victoria
      • Clayton, Victoria, Austrálie, 3168
        • Monash Heart

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

70 let a starší (Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • 1. Subject is ≥70 years of age
  • 2. Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of <1.0 cm2 (or AVA index of <0.6 cm2/m2) and either a mean pressure gradient >40 mm Hg or a jet velocity >4 m/s, as measured by echocardiography
  • 3. Subject has a documented aortic annulus size between ≥20 and ≤27 mm based on pre-procedure diagnostic imaging
  • 4. Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
  • 5. Subject is considered high risk for surgical valve replacement based on at least one of the following:

    1. Society of Thoracic Surgeons (STS) score ≥8%, AND/OR
    2. Agreement by the heart team (which must include an in-person evaluation by an experienced cardiac surgeon) that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement
  • 6. Heart team (which must include an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement.
  • 7. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
  • 8. 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:

  1. Subject has a congenital unicuspid or bicuspid aortic valve.
  2. Subject with an acute myocardial infarction within 30 days of 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).
  3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
  4. Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µmol/L.
  5. Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
  6. Subject has ≥3+ mitral regurgitation, ≥3+ aortic regurgitation or ≥3+ tricuspid regurgitation (i.e., subject cannot have more than moderate mitral, aortic or tricuspid regurgitation).
  7. Subject has a need for emergency surgery for any reason.
  8. Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
  9. Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
  10. Subject has Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
  11. Subject requires chronic anticoagulation therapy (warfarin) and cannot tolerate concomitant therapy with either aspirin or clopidogrel.

    Note: Subjects who require chronic anticoagulation must be able to be treated additionally with either aspirin or clopidogrel. An alternative P2Y12 inhibitor may be prescribed if subject is allergic to or intolerant of clopidogrel.

  12. Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
  13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, tantalum, titanium, or polyurethanes.
  14. Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.
  15. Subject has hypertrophic obstructive cardiomyopathy.
  16. Subject has any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to the index procedure (except for pacemaker implantation which is allowed).
  17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
  18. Subject has documented left ventricular ejection fraction <30%.
  19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  20. Subject has severe peripheral vascular disease (including aneurysm defined as maximal luminal diameter >5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [>5 mm], protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease.
  21. Femoral artery lumen of <6.0 mm for subjects requiring 23 mm valve size or <6.5 mm for subjects requiring 27 mm valve size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
  22. Current problems with substance abuse (e.g., alcohol, etc.).
  23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
  24. 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Lotus Valve Flex System
Transcatheter aortic valve replacement (TAVR) with Lotus Valve FLEX System
TAVR with Lotus Valve Flex System

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Technical success
Časové okno: immediately post-procedure
defined as successful vascular access, delivery and deployment of the Lotus Valve and successful retrieval of the delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location; reported as percent of subjects.
immediately post-procedure

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean aortic valve pressure gradient and effective orifice area
Časové okno: at discharge or 7 days post-procedure (whichever comes first)
as measured by echocardiography and assessed by an independent core laboratory
at discharge or 7 days post-procedure (whichever comes first)
Device performance
Časové okno: at discharge or 7 days post-procedure (whichever comes first)
defined as successful repositioning of the Lotus Valve if repositioning is attempted; and successful retrieval of the Lotus Valve if retrieval is attempted; and grade of paravalvular aortic regurgitation, as measured by echocardiography and assessed by an independent core laboratory
at discharge or 7 days post-procedure (whichever comes first)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mortality: all-cause, cardiovascular, and non-cardiovascular
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Stroke: disabling and non-disabling
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Composite of all-cause mortality and disabling stroke
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Bleeding: life-threatening (or disabling) and major
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Myocardial infarction (MI)
Časové okno: periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
Acute kidney injury: based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2
Časové okno: ≤7 days post index procedure
≤7 days post index procedure
Major vascular complication
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
New permanent pacemaker implantation resulting from new or worsened conduction disturbances (including new left bundle branch block [LBBB] and third degree atrioventricular block)
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
New onset of atrial fibrillation or atrial flutter
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Coronary obstruction
Časové okno: ≤7 days post procedure
≤7 days post procedure
Ventricular septal perforation, reported as percent of subjects
Časové okno: ≤7 days post procedure
≤7 days post procedure
Mitral apparatus damage, reported as percent of subjects
Časové okno: ≤7 days post procedure
≤7 days post procedure
Cardiac tamponade, reported as percent of subjects
Časové okno: ≤7 days post procedure
≤7 days post procedure
Prosthetic aortic valve malposition, including valve migration, valve embolization, ectopic valve deployment, or transcatheter aortic valve (TAV)-in-TAV deployment
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Prosthetic aortic valve thrombosis
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Prosthetic aortic valve endocarditis
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Prosthetic aortic valve performance
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Functional status
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
as evaluated by the New York Heart Association (NYHA) classification
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
Neurological status
Časové okno: at discharge and 1 year
as determined by the National Institutes of Health Stroke Scale (NIHSS)
at discharge and 1 year
Neurological status
Časové okno: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
as determined by the Modified Rankin Scale (mRS)
at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ian T Meredith, MD, PhD, Monash

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. prosince 2013

Primární dokončení (Aktuální)

10. prosince 2013

Dokončení studie (Aktuální)

10. prosince 2018

Termíny zápisu do studia

První předloženo

1. února 2017

První předloženo, které splnilo kritéria kontroly kvality

2. února 2017

První zveřejněno (Odhad)

6. února 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. července 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. července 2019

Naposledy ověřeno

1. července 2019

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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