NCT04464876Unknown不适用
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
InnovHeart3 个研究点 分布在 3 个国家目标入组 20 人开始时间: 2020年8月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Reduction of mitral regurgitation
研究概览
简要总结
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 years or older.
- •Severe functional mitral regurgitation (≥ Grade 3+).
- •NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- •Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.
- •Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.
- •Able to complete quality-of-life assessment (KCCQ).
排除标准
- •Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.
- •Life expectancy <1 yr due to noncardiac conditions.
- •Active endocarditis.
- •Active systemic infection.
- •Modified Rankin Scale ≥4 disability.
- •Hemodialysis/ chronic renal failure (eGFR < 35 mL/min/m2).
- •Pulmonary arterial hypertension (fixed PAS < 60mmHg). 8) COPD on home oxygen.
- •9) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).
- •11) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
- •12) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.
- •13) Participating in other investigational studies likely to confound the results or affect the study.
- •14) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients".
- •Cardiovascular Exclusion Criteria:
- •Myocardial infarction during prior 30 days.
- •Stroke or TIA during prior 30 days.
- •Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).
- •Prior mitral valve treatment (e.g. valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.
- •Prior surgical mechanical valve AVR.
- •Prior TAVI.
- •Need for any cardiovascular surgery or intervention (other than for MV disease) within 30 days.
- •CRT or ICD implanted in previous 30 days.
- •Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or IABP/mechanical circulatory support.
- •CABG or PCI within previous 30 days.
- •Adequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure. No need for revascularization.
- •Prior or planned heart transplantation (UNOS status 1).
- •Physical evidence of right-sided congestive heart failure:
- •Patients with ascites.
- •Patients with anasarca (generalized edema / hydropsy).
- •Procedural Exclusion Criteria:
- •Chest condition that prevents transapical access.
- •Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
- •Documented hypersensitivity to nickel or titanium.
- •Cardiac Exclusion Criteria (evaluated by Core Labs):
- •Left ventricular EF ≤ 30% by imaging.
- •Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
- •Extensive mitral flail leaflets.
- •Left ventricular thrombus, mass, or vegetation.
- •Left ventricular end-diastolic diameter > 7.5 cm.
- •Severe right ventricular dysfunction.
- •Significant intracardiac shunt.
- •Anatomic ineligibility for SATURN valve as determined by the Screening Committee.
结局指标
主要结局
Reduction of mitral regurgitation
时间窗: 30 days
Reduction of mitral regurgitation to ≤1 at 30 days.
Freedom from device-related or procedure-related major adverse events
时间窗: 30 days
Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).
Technical success
时间窗: Day 0
Technical success defined as alive patient at exit from procedure room, with all of the following: * Successful access, delivery and retrieval of the delivery systems. * Development and correct positioning of the bioprosthesis. * Freedom of additional emergency surgery or re-intervention related to the device or access procedure.
次要结局
- Patients success(30 days, 1 year, 2 years)
- Freedom from device-related or procedure-related major adverse events(30 days, 1 year, 2 years)
- NYHA functional classification(30 days, 1 year, 2 years)
- KCCQ(30 days, 1 year, 2 years)
- Freedom from all-cause mortality(30 days, 1 year, 2 years)
- Device success(30 days, 1 year, 2 years)
- 6 Minute Hall Walk Test(30 days, 1 year, 2 years)
研究者
研究点 (3)
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