REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Boston Scientific Corporation50 sites in 2 countries382 target enrollmentJanuary 14, 2019

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Boston Scientific Corporation
Enrollment: 382
Locations: 50
Primary Endpoint: Composite of All-cause Mortality and All Stroke.
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Detailed Description

To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.

Registry

clinicaltrials.gov

Start Date

January 14, 2019

End Date

March 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has documented severe aortic stenosis defined as initial aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mm Hg OR maximal aortic valve velocity ≥4.0 m/s OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction \<50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended)c; the subject may be enrolled if echocardiographic criteria are met with this augmentation. (IC1)
•A subject in the Bicuspid Aortic Valve Nested Registry cohort must have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on computed tomography (CT) assessment and confirmed by the CT core lab with hemodynamic parameters that meet the criteria in IC
•Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC\]).
•Subject has symptomatic aortic valve stenosis per IC1 definition above with New York Heart Association (NYHA) Functional Class ≥ II.
•Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is at intermediate risk of operative mortality (≥3% and \<8% at 30 days based on the Society of Thoracic Surgeons \[STS\] risk score and other clinical comorbidities unmeasured by the risk calculator) and TAVR is appropriate. Note: Risk of operative mortality must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).
•Heart team agrees that the subject is likely to benefit from valve replacement. IC
•Subject (or legal representative) has been informed of 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.
•Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

Exclusion Criteria

•Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the Bicuspid Nested Registry cohort).
•Subjects in the Bicuspid Nested Registry cohort will have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab. Subjects are not eligible for inclusion in the Bicuspid Nested Registry cohort if the maximum diameter of the ascending aorta is \>45 mm or if the subject has another indication for aortic root replacement. Subjects with a Sievers Type 2 bicuspid valve are not eligible for enrollment in any study cohort.
•Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation).
•Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
•Subject is on renal replacement therapy or has Glomerular Filtration Rate (GFR) \<20 (based on hospital preferred method). See AEC1 below if subject is in the CT Imaging Substudy.
•Subject has a pre-existing prosthetic aortic or mitral valve.
•Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
•Subject has moderate to severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or Dc).
•Subject has a need for emergency surgery for any reason.
•Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.

Outcomes

Primary Outcomes

Composite of All-cause Mortality and All Stroke.

Time Frame: 1 year post index procedure and device implantation

Pre-specified primary outcome measure in the protocol for the Main Cohort only. Critical safety events that are observed in the elderly population undergoing TAVR; assessments recommended by Valve Academic Research Consortium (VARC)