Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-septal TMVR System in Patients With Severe, Symptomatic Mitral Regurgitation (Cassini-US)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Technical (Implant) Success Endpoint
研究概览
简要总结
CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US).
The purpose of the study is to evaluate the technical (implant) feasibility, and safety, and performance of the SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation through a transcatheter approach.
Primary objectives evaluate the implant feasibility, and acute safety and performance of the SATURN TS TMVR System. The secondary objective and additional outcome measures characterize the long-term safety and performance of the SATURN TS TMVR System.
详细描述
The SATURN Bioprosthesis is designed to be implanted in the native mitral heart valve without open-heart surgery, extracorporeal circulation, cardiac arrest or removal of the failed native valve. The SATURN Bioprosthesis consists of the annular structure (Annular Segments) and the valve (SATURN Valve).
The valve supports a set of prosthetic leaflets that are the functional elements of the bioprosthesis. The valve is made of a self-expandable Nitinol frame supports three bovine pericardium leaflets. The valve is assembled with the annular structure through two connecting blocks mounted on the connecting arms of the stent.
The SATURN Delivery System and Accessories provides a transcatheter pathway to deliver the SATURN valve through the septum via the femoral vein. The SATURN Delivery System consists of an outer sheath, a guidewire delivery system, a valve delivery system and accessories.
The use of the SATURN TS System is carried out according to precise specifications and indications specified in the Instructions for Use (IFU) and is restricted to those physicians who have undergone dedicated training on use of the device.
Participants will be screened based on predefined inclusion and exclusion criteria. Eligible subjects will provide informed consent prior to any study-related procedures.
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
盲法说明
None (Open Label)
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.
- •Symptomatic, moderate to severe or severe, functional or mixed, mitral regurgitation (≥ Grade 3+).
- •NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- •Ability to tolerate oral anticoagulation.
- •Ability to qualify for bailout surgery (which may include open heart surgery).
- •High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team.
- •Willing and able to complete study-related assessments and questionnaires.
排除标准
- •Purely degenerative (organic/primary) (i.e. intrinsic valve lesions) mitral regurgitation.
- •Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement.
- •Life expectancy <1 yr. due to noncardiac conditions.
- •Endocarditis in the 3 months prior to procedure date.
- •Current admission with acute heart failure exacerbation.
- •Dependency on inotropic agents or mechanical circulatory support.
- •Untreated clinically significant CAD.
- •Active systemic infection.
- •Modified Rankin Scale ≥4 disability.
- •Chronic renal failure defined as eGFR < 30 mL/min/m2 or on renal replacement therapy.
- •Severe pulmonary arterial hypertension (PAH), defined as PASP > 70mmHg.
- •Platelets < 90,
- •COPD on home oxygen therapy deemed too high risk for intubation.
- •Refuses blood transfusions.
- •Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states).
- •Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
- •Participating in other investigational studies likely to confound the results or affect the study.
- •Unable or does not sign the study informed consent form.
- •Patients classified as "vulnerable patients"
- •Cardiovascular Exclusion Criteria
- •Myocardial infarction during prior 30 days.
- •Stroke or TIA during prior 90 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 planned cardiovascular surgery or intervention (other than for MV disease) within 30 days post-index procedure.
- •CRT, CRT-D, IPG 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.
- •Inadequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure, as reviewed by the Patient Screening Committee.
- •Prior or planned heart transplantation (UNOS status 1).
- •Physical evidence of right-sided CHF:
- •Patients with ascites.
- •Patients with anasarca (generalized edema / hydropsy).
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure with the exception of dilated ischemic or non-ischemic cardiomyopathy.
- •Procedural Exclusion Criteria
- •Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
- •Documented hypersensitivity to nickel or titanium.
- •Cardiac Imaging Exclusion Criteria (evaluated by Core Labs)
- •Contraindications to TEE imaging
- •Left ventricular EF ≤ 30% by echocardiogram.
- •Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
- •Extensive mitral flail leaflets
- •Evidence of new or untreated intracardiac thrombus, mass, or vegetation.
- •Severe right ventricular dysfunction.
- •Severe tricuspid regurgitation.
- •Hemodynamically significant inter-atrial shunt (ASD).
- •Severe aortic regurgitation or aortic stenosis.
- •Anatomic ineligibility for SATURN Valve or SATURN TS procedure as determined by the Screening Committee.
研究组 & 干预措施
SATURN TMVR Cohort
Saturn transseptal TMVR System implant
干预措施: Mitral Valve Replacement (Device)
结局指标
主要结局
Technical (Implant) Success Endpoint
时间窗: At completion of study procedure (Day 0)
Presented as the n/N (%) of patients that meet the definition of Implant Success per protocol.
Freedom from Major Adverse Events Endpoint
时间窗: 30 days from index procedure
Freedom from (n/N, %) device-related or procedure-related major adverse events (MAE) which include: Cardiovascular death, Peri-procedural myocardial infarction, Disabling stroke, Major cardiac structural complication, Major vascular complication, and Mitral reintervention (operative or transcatheter) due to progressive or recurrent MR or device-related complications.
Mitral Valve Effectiveness Endpoint (reduction in MR grade)
时间窗: 30 days post treatment
Defined as the reduction of mitral regurgitation Grade to ≤1+ at 30 days.
次要结局
- Mitral Valve Performance over time Endpoint(5 years post index procedure)