CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,150
- 试验地点
- 52
- 主要终点
- The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success
研究概览
简要总结
MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting.
Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease.
The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products.
Currently, three sub-studies are planned:
- MANTRA - Aortic Sub-Study
- MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D)
- MANTRA - Memo 4D Sub-Study
详细描述
The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple substudies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database.
Currently, three substudies are planned:
- MANTRA - Aortic Sub-Study
- MANTRA - Mitral/Tricuspid Sub-Study (excluding Memo 4D)
- MANTRA - Memo 4D Sub-Study
The aim of the studies assembled under the master protocol is the continued collection of safety and performance data during heart valve procedures and the relevant follow-up visits in subjects where any of the CORCYM devices and accessories are used in a real-world setting, in accordance with the IFUs, and at the discretion of the investigator.
MANTRA study is expected to enroll approximately 2150 subjects in up to 130 sites worldwide:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated approved Informed Consent
- •Subject is willing and able to comply with the follow up schedule of the protocol
- •Eligible for treatment with CORCYM aortic, mitral and/or tricuspid products as outlined in the applicable Instructions for Use (IFU)
排除标准
- •Subject is already participating to another clinical investigation that could confound the results of this clinical investigation.
- •Subject has a life expectancy ≤ 12 months
- •Subject has contraindications to the use of CORCYM aortic, mitral and/or tricuspid devices as outlined in the applicable Instructions For Use (IFU)
结局指标
主要结局
The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success
时间窗: 30 days
Device success at 30 days (+14 days) based on VARC-3, defined as: * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient\<20 mmHg and less than moderate aortic regurgitation) The number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success
时间窗: 30 days
Device success at 30 days (+14 days) based on MVARC, defined as: * Procedural mortality or stroke AND * Proper placement and positioning of the device AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * MITRAL: Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels (site-reported) * TRICUSPID: Reduction of Tricuspid Regurgitation (TR) to either optimal or acceptable levels (site-reported) Number and percentage of subjects with device success, along with individual component, will be presented.
The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success
时间窗: 30 days
Device success at 30 days (+14 days) based on the MVARC, defined as: * Procedural mortality or stroke; AND * Proper placement and positioning of the device; AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure; AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels without significant mitral stenosis (i.e., post-procedure EOA is ≥ 1.5 cm2 with a transmitral gradient \<5 mmHg), and with no greater than mild MR core-lab assessed The number and percentage of subjects with device success at 30 days as per MVARC definition, along with individual component of the success, will be presented.
次要结局
- Valve-related long-term clinical efficacy(at 5 years and up to 10 years)
- Major Adverse Cardiovascular and Cerebrovascular Event (MACCE - composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention)(up to 10 years from implant)
- Technical success(intraoperatively)
- Clinical Efficacy (AORTIC sub-study)(12 months)
- Bioprosthetic Valve Dysfunction (BVD), including Structural Valve Deterioration (SVD), Non structural valve dysfunction (NSVD), Thrombosis and Endocarditis(up to 10 years from implant)
- Patient outcome (New York Heart Association (NYHA) Classification)(up to 10 years from implant)
- Mortality (all-cause mortality, cardiovascular mortality, device related mortality)(up to 10 years from implant)
- Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)(up to 10 years from implant)
- Hemodynamic and structural performance(up to 10 years from implant)
- Patient outcome (Kansas City Cardiomyopathy Questionnaire (KCCQ-12); and EQ-5D-5L (in patients treated with Perceval Plus)(12 months)