REPRISE EDGE 29 mm EU Study

NCT02964962 | Withdrawn

• 1 other identifier: S2351
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical aortic valve replacement (SAVR).

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory.

  30 days post-procedure

Study Arms (1)

29 mm LOTUS Edge™

EXPERIMENTAL

Device: 29 mm LOTUS Edge™ Valve System

Interventions

29 mm LOTUS Edge™ Valve System DEVICE

Transcatheter aortic valve replacement

29 mm LOTUS Edge™

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and/or invasive hemodynamics.
• Subject has a documented aortic annulus size of ≥27 mm and ≤29 mm based on the site's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC\]).
• Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.
• There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see Note 5 below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate.
• Additionally, subject has at least one of the following:
• Society of Thoracic Surgeons (STS) score ≥8% -OR-
• If STS \<8, subject has at least one of the following conditions:
• Hostile chest
• Porcelain aorta
• Severe pulmonary hypertension (\>60 mmHg)
• Prior chest radiation therapy
• Coronary artery bypass graft(s) at risk with re-operation
• Severe lung disease (need for supplemental oxygen, FEV1 \<50% of predicted, DLCO \<60%, or other evidence of severe pulmonary dysfunction)
• Neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement
• Orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement

You may not qualify if:

• 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 level elevation).
• Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment.
• Subject has end-stage renal disease or has GFR \<20 (based on Cockcroft-Gault formula).
• Subject has a pre-existing prosthetic aortic or mitral valve.
• Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
• 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.
• Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
• 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/mm3.
• Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel.
• Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
• Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes.
• Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
• Subject has hypertrophic obstructive cardiomyopathy.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 16, 2016
• Study Start: April 1, 2018
• Primary Completion: October 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share