NCT01831544终止不适用
Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure
Medtronic Cardiac Rhythm and Heart Failure22 个研究点 分布在 5 个国家目标入组 11 人开始时间: 2015年7月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 22
- 主要终点
- Survival
研究概览
简要总结
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure
详细描述
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure. The primary endpoint is survival at 6 months presented as a simple proportion (subjects alive on the MVAD® pump divided by endpoint eligible subjects). Secondary endpoints include the incidence of bleeding, incidence of major infections (per INTERMACS definitions), time to death, incidence of all device failures and device malfunctions, Health Status improvement, and Functional status improvement. Safety measures will include the frequency and rates of adverse events, overall and for each specific event, which will be collected throughout VAD support.
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
- •Must be ≥18 years of age at consent
- •Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following):
- •on optimal medical management including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or
- •in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes.
- •Left ventricular ejection fraction ≤25%.
- •Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
- •The subject has signed the informed consent form.
排除标准
- •Body Mass Index (BMI) >
- •Body Surface Area (BSA) < 1.0 m
- •Partial or full mechanical circulatory support within thirty days of implant.
- •Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA®.
- •Prior cardiac transplant or cardiomyoplasty.
- •History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter > 5 cm).
- •Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities.
- •On ventilator support for > 72 hours within the four days immediately prior to implant.
- •Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan.
- •Symptomatic cerebrovascular disease, stroke within 180 days of implant or > 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation
- •Uncorrected moderate to severe aortic insufficiency.
- •Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening.
- •Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.
- •Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, International Normalized Ratio (INR) > 2.0 or Partial Thromboplastin Time (PTT) > 2.5 times control in the absence of anticoagulation therapy).
- •Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the subject's health status.
- •Serum creatinine > 3.0 mg/dL within 72 hours of implant or requiring dialysis.
- •Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)] > 3 times upper limit of normal within 72 hours of implant.
- •A total bilirubin > 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension.
- •Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation.
- •Subjects with a mechanical heart valve.
- •Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
- •History of severe COPD or severe restrictive lung disease (e.g. FEV1 < 50% predicted value).
- •Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial.
- •Severe illness, other than heart disease, which would limit survival to < 3 years.
- •Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
- •Pregnancy and breast feeding.
- •Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD.
- •Subject unwilling or unable to comply with trial requirements.
- •Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
- •Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members or employees of the investigator.
结局指标
主要结局
Survival
时间窗: Six month
Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
次要结局
- Survival(Two years)
- Survival: Number of Participants Who Died by Six Months and Two Years(Six months and two years)
- Incidence of Major Bleeding(Six months and two years)
- Incidence of All Device Failures and Device Malfunctions(Six months and two years)
- Incidence of Major Infection(Six months and two years)
- Incidence of Neurological Dysfunction(Six months and two years)
- Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L(Six month and 24 month visit)
- Functional Status Change, as Measured 6-minute Walk(6 month and 24 month visit)
- Frequency and Rates of Adverse Events(AEs)(Six months and two years)
- Length of Initial Hospital Stay (Days)(Post operation)
- Re-Hospitalizations(On or before 6 months follow-up and 24 month follow-up)
- Transplantations(Six months and two years)
- Explants(Six months and two years)
- New York Heart Association (NYHA) Functional Classification Score(Baseline and 6 month and 24 month visit)
- Length of Operative Time (Hours)(Implant)
研究者
研究点 (22)
Loading locations...
相似试验
Unknown
不适用
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.Hemodialysis Access FailureNCT04285073Samsung Medical Center20
进行中（未招募）
不适用
PREEMIE: Study for Treatment of PDA in Premature InfantsPatent Ductus Arteriosus (PDA)NCT06587282Merit Medical Systems, Inc.55
已完成
不适用
HAART Model 300 Annuloplasty RingAortic RegurgitationNCT01400841Biostable Science & Engineering18
已完成
不适用
Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ ProlapseAnterior Vaginal Wall Prolapse With/Without Apical/Uterine DescentNCT03195361Lyra Medical Ltd.50
已完成
不适用
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPAAtherosclerosisNCT03455855Boston Scientific Corporation72