NCT05455489招募中不适用
The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
Fondazione GISE Onlus1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2023年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- percentage of participants with a mitral regurgitation (MR)
研究概览
简要总结
The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers ("more-comers") population with symptomatic severe mitral regurgitation undergoing/undergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy AND
- •Left Ventricular End-Systolic Dimension <70 mm
- •Mitral Valve area > 4 cmq
- •Left ventricular ejection fraction ≥20%
- •NYHA functional class II, III, ambulatory IV
- •brain natriuretic peptide BNP ≥300 pg/ml or N-terminal prohormone of brain natriuretic peptide NT-proBNP ≥1500 pg/ml and/or at least one hosp for HF (Heart failure) in the 12 months prior to enrollment
- •Age 18 years or older
- •Subject has been adequately treated per applicable standards, including for coronary artery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF
- •Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) AND
- •Mobile mitral valve (MV) length of PL ≥8 mm in case of NT device, ≥10 mm in case of XT device
- •MV area > 4 cm2
- •NYHA functional class > II
- •Age 18 years or older
- •Local HT decision In case of patients with a coexistence of both etiologies, they will be assigned to a subgroup based on the prevailing mechanism.
- •THE MULTIPARAMETRIC ALGORITHM FOR MR GRADING The multiparametric algorithm, adapted from the criteria recommended by the American Society of Echocardiography 2003 Guidelines and based on 3 tiers of evaluation, will be used for qualification purposes to determine if MR was 3+ or higher. The 3 tiers of evaluation are applied in a hierarchical manner (from tier 1 to 3) and patients qualified for TEER by meeting the criteria of at least one of them. For MR grading purposes, MR severity was subsequently graded as 3+ or 4+ based on the integrative evaluation of multiple parameters recommended by the The American Society of Echocardiography (ASE)
排除标准
- •Significant right ventricular disfunction (TAPSE<15 mm and/or S'<8cm/s)
- •Systolic pulmonary artery > 70 mmHg with irreversible precapillary pulmonary hypertension
- •Severe TR Tricuspid valve regurgitation
- •Hemodynamic instability/NYHA IV
- •Impaired mobility as a result of neurological or musculoskeletal disease, or advanced dementia
- •Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathies
- •CABG coronary artery bypass graft, PCI percutaneous coronary intervention, TAVR transcatheter aortic valve replacement, CVA cardiovascular accident within the prior 60 days
- •Life expectancy <12 months due to non-cardiac conditions
- •Active infections
- •Advanced HF (ESC/HFA Heart Failure Association Criteria) or Bridge tp to HTx/LVAD (left ventricular assist device)
结局指标
主要结局
percentage of participants with a mitral regurgitation (MR)
时间窗: at 1 year
grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.
次要结局
- composite of all-cause death and hospitalization for heart failure (HF),(at 5 years)
研究者
研究点 (1)
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