REPRISE China: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Edge™ Valve System - Clinical Evaluation in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stenoses, Aortic Valve
- Sponsor
- Boston Scientific Corporation
- Locations
- 1
- Primary Endpoint
- All-cause mortality
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic stenosis who are considered at high risk for surgical valve replacement.
Detailed Description
1. A independent Clinical Events Committee (CEC) will adjudge the safety endpoint. 2. 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 \[CRC\]). 3. Monitor will review the source data regularly to compare the EDC to ensure the data entry can be accuracy, completeness, or representativeness. 4. Will recruit maximum 62 subjects in maximum 6 sites 5. Boston Scientific's Standard Operating Procedures to address operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 70 years.
- •Subject has documented calcific, severe native aortic stenosis with an initial AVA of \<1.0 cm2 (or AVA index of \<0.6 cm2/m2), and a mean pressure gradient ≥40 mm Hg or jet velocity ≥4.0 m/s or doppler velocity index ≤0.25, as measured by echocardiography and/or invasive hemodynamics.
- •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 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 operative risk for surgical valve replacement (see note below for definition of 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)
Exclusion Criteria
- •Subject has a congenital unicuspid aortic valve or Sievers Type 2 bicuspid aortic valve.
- •Subject has had an acute myocardial infarction within 30 days prior to 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 prior to study enrollment.
- •Subject has end-stage renal disease or has serum creatinine \> 3mg/dl or has creatinine clearance rate \<45ml/min.
- •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 platelet count \< 50,000 cells/mm3 (50×109/L) or \> 700,000 cells/mm3 (700×109/L), or white blood cell count \< 1,000 cells/mm3 (1×109/L).
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: Through 30 days post index procedure
All-cause mortality through 30 days post index procedure.
Mean aortic valve pressure gradient
Time Frame: At 30 days post index procedure
Mean aortic valve pressure gradient at 30 days post index procedure.