REPRISE NGDS: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With the Next Generation Delivery System

Boston Scientific Corporation2 sites in 1 country38 target enrollmentDecember 3, 2014

ConditionsAortic Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Stenosis
Sponsor: Boston Scientific Corporation
Enrollment: 38
Locations: 2
Primary Endpoint: Technical Success
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery 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 demonstrate that the acute performance and safety of the LOTUS Edge Valve System when used with the iSleeve Introducer Set or current Lotus Introducer Set are consistent with the results of the Lotus Valve System used 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, 2014

End Date

October 19, 2017

Last Updated

7 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 ≤27.5 mm based on pre-procedure diagnostic imaging
•Subject has 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 creatine kinase-myoglobin band (CK-MB) elevation and/or troponin level 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 µml/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 (patient discharged from operative room)

Defined as successful vascular access, delivery, and deployment of the Lotus Valve; successful retrieval with the Lotus Next Generation delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location (reported as percent of subjects implanted with a Lotus Valve). Reported as percent of subjects.

Secondary Outcomes

Mild, trace/trivial, or no paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory(At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Stroke: disabling and non-disabling(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Severe or moderate paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory(At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory(At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Peak aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory(At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Successful repositioning of the study valve if repositioning is attempted(Immediately post-procedure (patient discharged from operative room))
Peak aortic velocity as measured by echocardiography and assessed by an independent core laboratory(At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Major vascular complications major(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
New permanent pacemaker implantation resulting from new or worsened conduction disturbances(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Cardiac tamponade(≤72 hours post index procedure)
Prosthetic aortic valve endocarditis(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Successful retrieval of the study valve if retrieval is attempted(Immediately post-procedure (patient discharged from operative room))
Mortality: all-cause, cardiovascular, and non-cardiovascular(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Acute kidney injury based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2(≤7 days post index procedure)
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Coronary obstruction(≤72 hours post index procedure)
Ventricular septal perforation(≤72 hours post index procedure)
Prosthetic aortic valve thrombosis(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Effective orifice area as measured by echocardiography and assessed by an independent core laboratory(At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Bleeding: life-threatening (or disabling) and major(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
New onset of atrial fibrillation or atrial flutter(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Neurological status per modified Rankin Scale score(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Neurological status per National Institutes of Health Stroke Scale(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Functional Improvement from baseline per NYHA functional classification(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Mitral apparatus damage(≤72 hours post index procedure)
Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)
Transcatheter aortic valve (TAV)-in-TAV deployment(At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure)