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

Boston Scientific Corporation2 sites in 1 country4 target enrollmentDecember 3, 2013

ConditionsAortic Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Stenosis
Sponsor: Boston Scientific Corporation
Enrollment: 4
Locations: 2
Primary Endpoint: Technical success
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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).

Registry

clinicaltrials.gov

Start Date

December 3, 2013

End Date

December 10, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥70 years of age
•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
•Subject has a documented aortic annulus size between ≥20 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 based on at least one of the following:
•Society of Thoracic Surgeons (STS) score ≥8%, AND/OR
•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
•Heart team (which must include 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.

Exclusion Criteria

•Subject has a congenital unicuspid or bicuspid aortic valve.
•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).
•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 has ≥3+ mitral regurgitation, ≥3+ aortic regurgitation or ≥3+ tricuspid regurgitation (i.e., 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 Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm

Outcomes

Primary Outcomes

Technical success

Time Frame: 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.

Secondary Outcomes

Mean aortic valve pressure gradient and effective orifice area(at discharge or 7 days post-procedure (whichever comes first))
Device performance(at discharge or 7 days post-procedure (whichever comes first))