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REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

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ClinicalTrials.gov Identifier: NCT01627691
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : September 10, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE June 5, 2012
First Posted Date  ICMJE June 26, 2012
Results First Submitted Date  ICMJE May 20, 2019
Results First Posted Date  ICMJE September 10, 2019
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE October 8, 2012
Actual Primary Completion Date May 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure [ Time Frame: 30 days ]
    Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
  • Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure [ Time Frame: 30 days ]
    Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2012)
  • Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure [ Time Frame: 30 days ]
    Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
  • Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure [ Time Frame: 30 days ]
    All-cause mortality at 30 days post implant procedure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • Effective Orifice Area [ Time Frame: 30 days ]
    Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)
  • Device Performance Endpoint: Successful Vascular Access [ Time Frame: Post-procedure ]
    Successful vascular access, delivery and deployment of the Lotus Valve System and successful retrieval of the delivery system as reported from site
  • Device Performance Endpoint: Successful Retrieval [ Time Frame: Post-procedure ]
    Successful retrieval (complete resheathing of the Lotus valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted, as reported from site
  • Device Performance Endpoint: Successful Repositioning [ Time Frame: Post-procedure ]
    Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted, as reported from site
  • Device Success According to the Valve Academic Research Consortium (VARC) [ Time Frame: Post-procedure ]
    Absence of procedural mortality as reported from site AND Correct positioning of a single prosthetic heart valve into the proper anatomical location as reported from site AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation as measured from an independent core lab on the post-procedure echocardiography)
  • Grade of Aortic Valve Regurgitation [ Time Frame: 30 days ]
    Grade of paravalvular aortic valve regurgitation at 30 days as measured by echocardiography and assessed by an independent core laboratory
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
Official Title  ICMJE REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance
Brief Summary The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.
Detailed Description The REPRISE II clinical study is a prospective, single-arm, multicenter study designed to evaluate the safety and performance of the Lotus Valve System for TAVR in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transcatheter Aortic Valve Replacement
Intervention  ICMJE Device: Lotus Valve System
  • bioprosthetic bovine pericardial aortic valve
  • delivery system
Study Arms  ICMJE Experimental: Lotus Valve System
Patients enrolled will receive the Lotus Valve.
Intervention: Device: Lotus Valve System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2017)
250
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2012)
120
Actual Study Completion Date  ICMJE May 13, 2019
Actual Primary Completion Date May 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is ≥70 years of age
  • Subject has documented calcific native aortic valve stenosis
  • Subject has a documented aortic annulus size between ≥19 and ≤27 mm based on pre-procedure diagnostic imaging
  • Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II
  • Subject is considered high risk for surgical valve replacement
  • Heart team 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 or bicuspid aortic valve.
  • Subject with an acute myocardial infarction within 30 days of the index procedure
  • 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.
  • Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µmol/L.
  • Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
  • subject cannot have more than moderate mitral, aortic or tricuspid regurgitation
  • Subject has a need for emergency surgery for any reason.
  • Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
  • Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
  • Subject has low Hgb, platelet count or >700,000 cells/mm3, or low white blood cell count.
  • Subject requires chronic anticoagulation therapy and cannot tolerate concomitant therapy with either aspirin or clopidogrel/ticlopidine
  • Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
  • 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.
  • 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.
  • Subject has hypertrophic obstructive cardiomyopathy.
  • Subject has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure (except for pacemaker implantation which is allowed).
  • Subject has untreated coronary artery disease.
  • Subject has documented left ventricular ejection fraction <30%.
  • Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  • Subject has severe peripheral vascular disease or symptomatic carotid or vertebral disease.
  • Narrow Femoral artery lumen precludes the use of either Lotus device size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
  • 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.
  • Patient has preexisting untreated conduction system disorder that requires new pacemaker implantation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01627691
Other Study ID Numbers  ICMJE TP3687
TP3687 ( Other Identifier: Boston Scientific )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicolas Dumonteil, MD Clinique Pasteur
PRS Account Boston Scientific Corporation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP