REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm (REPRISE I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01383720
First received: June 27, 2011
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.


Condition Intervention Phase
Calcified Stenotic Native Aortic Valves
Device: Transcatheter aortic valve implantation with the Lotus Valve System
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Clinical Procedural Success [ Time Frame: Discharge or 7 days post-procedure, whichever comes first ] [ Designated as safety issue: Yes ]
    Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.


Secondary Outcome Measures:
  • Device performance endpoints [ Time Frame: peri- and post-procedure ] [ Designated as safety issue: No ]
    • Successful repositioning of the Lotus Valve System if repositioning is attempted.

  • Device performance endpoints [ Time Frame: peri- and post-procedure ] [ Designated as safety issue: No ]
    • Successful retrieval of the Lotus Valve System if retrieval is attempted.

  • Incidence of aortic regurgitation (central and paravalvular) [ Time Frame: peri- and post-procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: April 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotus Valve System Device: Transcatheter aortic valve implantation with the Lotus Valve System
The Lotus Valve System consists of the Lotus Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve, and the Lotus Delivery Catheter, a delivery system for guidance and placement of the Lotus Valve.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be at least 70 years of age or older, and meets all of the criteria below.
  2. Patient has documented calcified native aortic valve stenosis, defined with an initial aortic valve area of <1.0 cm2 (or AVA index of <0.6 cm2/m2), and a mean pressure gradient >40 mmHg or a jet velocity >4 m/s, as measured by echocardiography.
  3. The patient is considered at high risk for surgical aortic valve replacement with an STS score ≥8% or a EuroSCORE ≥20%, or documented multidisciplinary heart team agreement that the patient is at high risk for surgery due to frailty and/or coexisting comorbidities.
  4. Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.
  5. Patient has a documented aortic annulus size between 19 and 22 mm (able to accommodate the 23 mm Lotus™ Valve). Pre-procedure measurement by transthoracic echocardiography (TTE) is required. Other imaging modalities (e.g., transesophageal echocardiography (TEE), CT scan) can be used in an adjunctive manner.
  6. Patient (or legal representative) understands the trial requirements and the treatment procedures, and provides written informed consent.
  7. Patient agrees and is capable of returning to the study hospital for all required scheduled follow up visits.

Exclusion Criteria:

  1. Patient has a congenital unicuspid or bicuspid aortic valve.
  2. Patient 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 level elevation (WHO definition)).
  3. Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
  4. Patient is on dialysis or has serum creatinine level >3.0 mg/dL.
  5. Patient has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
  6. Patient has >2+ mitral regurgitation or >2+ aortic regurgitation (ie., patient cannot have more than moderate mitral or aortic regurgitation).
  7. Moderate to severe pulmonary hypertension (PA systolic pressure >60 mm Hg) as assessed by transthoracic echocardiography.
  8. Patient has a need for emergency surgery for any reason.
  9. Patient has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
  10. Patient has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
  11. Patient has Hgb <9 g/dL, platelet count <100,000 cells/mm3 or >700,000 cells/mm3, and white blood cell (WBC) count <3,000 cells/mm3.
  12. Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, warfarin) and who cannot tolerate concomitant therapy with aspirin and clopidogrel (patients who require chronic anticoagulation must be treated with either aspirin or clopidogrel).
  13. Patient has active peptic ulcer disease, gastrointestinal (GI) bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
  14. Patient is contraindicated for transesophageal echocardiography (TEE).
  15. Patient has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, titanium, or polyurethanes.
  16. Patient 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.
  17. Patient has other cardiac devices or hardware with which the study device will interfere with device placement (per physician judgment).
  18. Patient has hypertrophic obstructive cardiomyopathy.
  19. Patient has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure.
  20. Untreated clinically significant coronary artery disease requiring revascularization.
  21. Patient has documented LVEF <30%.
  22. Patient is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  23. Patient has severe peripheral vascular disease (including aneurysm defined as maximal luminal diameter >5cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick (>5mm), protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease.
  24. Patient has a femoral artery lumen of <6.0 mm or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
  25. Current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc).
  26. Patient is participating in another investigational drug or device study that has not reached its primary endpoint.
  27. Patient has preexisting untreated conduction system disorders: Type II second-degree AV block, bifascicular or trifascicular block.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383720

Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Southern Health Monash Medical Centre
Melbourne, Victoria, Australia, 3168
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3040
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Ian Meredith, MBBS, PhD Southern Health, Monash Medical Centre
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01383720     History of Changes
Other Study ID Numbers: TP3659
Study First Received: June 27, 2011
Last Updated: April 27, 2012
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Boston Scientific Corporation:
Symptomatic patients with calcified stenotic native aortic valves and who are considered high risk for surgical valve replacement

ClinicalTrials.gov processed this record on August 18, 2014