REPRISE China - Clinical Evaluation in China
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|ClinicalTrials.gov Identifier: NCT03084510|
Recruitment Status : Withdrawn (study device was recalled.)
First Posted : March 21, 2017
Last Update Posted : December 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stenoses, Aortic Valve||Device: Lotus Edge™ Valve System||Not Applicable|
- A independent Clinical Events Committee (CEC) will adjudge the safety endpoint.
- 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]).
- Monitor will review the source data regularly to compare the EDC to ensure the data entry can be accuracy, completeness, or representativeness.
- Will recruit maximum 62 subjects in maximum 6 sites
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||REPRISE China: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Edge™ Valve System - Clinical Evaluation in China|
|Actual Study Start Date :||February 28, 2020|
|Actual Primary Completion Date :||November 30, 2020|
|Actual Study Completion Date :||November 30, 2020|
Experimental: Lotus Edge™ Valve System
The Lotus Edge™ Valve System is intended to improve the aortic valve function for symptomatic patients with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Device: Lotus Edge™ Valve System
• The Lotus Edge™ Valve System consisting of two main components:
- 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.
- Safety endpoints adjudicated by an independent Clinical Events Committee (CEC) [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]Mortality: all-cause, cardiovascular, and non-cardiovascular Stroke: disabling and non-disabling Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure) Bleeding: life-threatening (or disabling) and major Acute kidney injury (≤7 days post index procedure): based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2 Major vascular complication Repeat procedure for valve-related dysfunction (surgical or interventional therapy) Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
- Device Performance [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]Successful vascular access, delivery and deployment of the study valve, and successful retrieval of the delivery system Successful retrieval of the study valve if retrieval is attempted Successful repositioning of the study valve if repositioning is attempted Grade of aortic valve regurgitation: paravalvular, central, and combined
- Procedural success [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]device and/or procedure related serious adverse events (SAEs) and death, correct positioning of a single transcatheter valve into the proper anatomical location, intended performance of the study device (effective orifice area [EOA] >0.9 cm2 for BSA <1.6 m2 and EOA >1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity <3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) at discharge or 7 days post-procedure (whichever comes first)
- prosthetic aortic valve performance as measured by transthoracic echocardiography (TTE) [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation
- New York Heart Association (NYHA) [ Time Frame: peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 , 12, 24, 36, 48 & 60 months post index procedure ]New York Heart Association (NYHA) functional classification
- Paravalvular aortic regurgitation [ Time Frame: At 30 days and 12 months ]Moderate or greater paravalvular aortic regurgitation (based on core lab assessment) at 30 days and 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084510
|Cardiovascular Institute and Fu Wai Hospital|
|Study Chair:||Zhiyu Zeng, Doctor||BSC|