NCT02520310已完成不适用
A Prospective, Multi-Center, Single-Arm Clinical Evaluation of the AVJ-514 System for the Treatment of Symptomatic Chronic Severe Mitral Regurgitation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Number of Participants With Acute Procedure Success (APS)
研究概览
简要总结
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.
详细描述
This study is a prospective, multi-center, single-arm clinical evaluation of the AVJ-514 System for the treatment of symptomatic chronic severe mitral regurgitation (MR) in Japanese subjects deemed difficult for mitral valve surgery by the local site heart team.
Patients will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years in Japanese Medical Centers.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria:
- •Age 20 years or older.
- •Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE.
- •Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment).
- •New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV.
- •Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors:
- •Porcelain aorta or mobile ascending aortic atheroma
- •Post-radiation mediastinum
- •Previous mediastinitis
- •Functional MR with LVEF < 40%
- •Over 75 years old with LVEF < 40%
- •Re-operation with patent grafts
- •Two or more prior cardiothoracic surgeries
- •Hepatic cirrhosis
- •Other surgical risk factor(s)
- •Mitral valve area ≥ 4.0 cm2 assessed by ECL based TTE within 90 days prior to subject registration. The ECL may request a TEE.
- •Left Ventricular End Systolic Dimension (LVESD) is ≤ 60mm assessed by site based on the TTE obtained within 90 days prior to subject registration.
- •The primary regurgitant jet is non-commissural based on TEE, and in the opinion of the AVJ-514 implanting investigator can successfully be treated by the AVJ-
- •If a secondary jet exists, it must be considered clinically insignificant.
- •Transseptal catheterization and femoral vein access is determined to be feasible by the treating physician.
- •The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
排除标准
- •Subjects must not meet any of the following exclusion criteria:
- •LVEF is < 30%
- •Leaflet anatomy which may preclude AVJ-514 implantation, proper positioning on the leaflets or sufficient reduction in MR by the AVJ-514 based. This evaluation is based on TEE evaluation of the mitral valve within 180 days prior to subject registration and includes:
- •Insufficient mobile leaflet available for grasping with the AVJ-514 device
- •Lack of both primary and secondary chordal support in the grasping area
- •Evidence of significant calcification in the grasping area
- •Presence of a significant cleft in the grasping area
- •Life expectancy < 1 year due to associated non-cardiac co-morbid conditions
- •Need for emergent or urgent surgery for any reason
- •Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure.
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
- •Untreated clinically significant coronary artery disease requiring revascularization or significant myocardial ischemia or evidence of an acute myocardial infarction in the prior 90 days of registration.
- •Cerebrovascular accident within 180 days prior to registration
- •Severe symptomatic carotid stenosis (> 70% by ultrasound)
- •Any cardiac surgery within 180 days prior to registration
- •Percutaneous coronary intervention (PCI) within the last 30 days prior to registration
- •Implant of Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy with Cardioverter Defibrillator (CRT-D) pacemaker or Implantable Cardioverter Defibrillator (ICD)within the last 30 days prior to registration.
- •Transcatheter aortic valve replacement (TAVR) within the last 30 days prior to registration.
- •Severe tricuspid regurgitation or aortic valve disease requiring surgical treatment.
- •In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
- •Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction drug or cardiogenic shock or intra-aortic balloon pump.
- •History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
- •Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll at least 14 days after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 21 days prior to treatment.
- •Intravenous drug abuse or suspected inability to adhere to follow-up.
- •Patients in whom TEE is contraindicated.
- •A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.
- •In the judgment of the Investigator, subjects in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.
- •Subject intends to participate in any other investigational or invasive clinical study within a period of 1 year following the AVJ-514 procedure.
- •Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
- •In the opinion of the investigator or designee, subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
- •In the opinion of the anesthesiologist, general anesthesia is contraindicated.
- •Pregnant or planning pregnancy within next 1 year.
结局指标
主要结局
Number of Participants With Acute Procedure Success (APS)
时间窗: On day 0 (the day of procedure)
APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.
次要结局
- All-cause Mortality(5 years)
- Percentage of Participants With Major Adverse Events (MAE) at 30 Days(30 days)
- Percentage of Participants With MAE at 1 Year(1 year)
- Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access(30 days)
- Number of Participants With Mitral Valve Stenosis Requiring Surgery(1 year)
- Number of Participants With Mitral Valve Stenosis Not Requiring Surgery(1 year)
- MR Severity Grade(5 years)
- Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery(1 year)
- Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery(1 year)
- Number of Participants With Iatrogenic Atrial Septal Defect(30 days)
- Percentage of Participants With Device Implant Rate(On the day of procedure)
- Device Procedure Time(On the day of procedure)
- Total Procedure Time(On the day of procedure)
- Device Time(On the day of procedure)
- Fluoroscopy Duration(On the day of procedure)
- Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)(At Discharge (≤ 14.4 ± 8.5 days post index procedure))
- Length of Hospital Stay Excluding Rehabilitation Stay(At Discharge (≤ 14.4 ± 8.5 days post index procedure))
- Length of Rehabilitation Stay(At Discharge (≤ 14.4 ± 8.5 days post index procedure))
- Number of Participants With MR Severity Grade(1 year)
- Regurgitant Volume (RV)(5 years)
- Percentage of Participants With Discharge Status(At Discharge (≤ 14.4 ± 8.5 days post index procedure))
- Length of Stay (Not at Baseline Facility)(At Discharge (≤ 14.4 ± 8.5 days post index procedure))
- Number of Participants With Mitral Regurgitation (MR) Severity Grade(At baseline (Within 14 days prior to the AVJ-514 procedure))
- Regurgitant Fraction (RF)(4 year)
- Left Ventricular End Diastolic Volume (LVEDV)(5 years)
- Left Ventricular End Systolic Volume (LVESV)(5 years)
- Left Ventricular End Diastolic Dimension (LVEDD)(5 years)
- Left Ventricular End Systolic Dimension (LVESD)(5 years)
- Left Ventricular Ejection Fraction (LVEF)(5 years)
- Pulmonary Artery Systolic Pressure (PASP)(5 years)
- Mitral Valve Area (MVA)(5 years)
- Mitral Valve Area(MVA)(1 year)
- Mean Mitral Valve Pressure Gradient (MVG)(5 years)
- Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)(1 year)
- Systolic Anterior Motion of the Mitral Valve (Present or Absent)(5 years)
- Forward Stroke Volume (FSV)(5 years)
- Cardiac Output (CO)(5 years)
- Cardiac Index (CI)(5 years)
- Number of Participants With All-cause Mortality(1 year)
- Number of Participants With the Primary Safety Composite of MAE at 1 Year(12 months)
- Freedom From the Components of the Primary Safety Composite of MAE(5 years)
- Number of Patients With New York Heart Association (NYHA) Functional Class(At baseline (Within 14 days prior to the AVJ-514 procedure))
- Number of Participants With NYHA Functional Class(1 year)
- NYHA Functional Class(5 years)
- Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores(At baseline (Within 14 days prior to the AVJ-514 procedure))
- KCCQ QoL Scores(5 years)
- Change in KCCQ QoL Scores From Baseline to 1 Year(Baseline to 1 Year)
- SF-36 QoL Scores(24 months)
- Change in SF-36 QoL Scores From Baseline to 1 Year(From baseline to 1 year)
- Change in SF-36 QoL Scores From Baseline(At 24 months)
- Number of Participants Undergoing Mitral Valve Surgery(Through 5 years)
- Mitral Stenosis(5 years)
- Number of Participants With Additional Mitra Clip Device Intervention(Through 5 years)
- Six Minute Walk Test (6MWT) Distance(5 years)
- Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year(Baseline to 1 year)
- Changes in Six Minute Walk Test (6MWT) Distance From Baseline(At 24 months)
- Number of Participants With Mitral Valve Surgery(1 year)
- Number of Participants With Additional AVJ-514 Device Intervention(1 year)
- Number of Hospitalizations and Reason for Hospitalization(1 year post index procedure)
- Number of Hospitalizations(5 years)
- Number of Participants With Mitral Stenosis(1 year)
- Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention(12 months)
- Number of Participants With Clinically Significant ASD That Requires Intervention(5 years)
- Number of Participants With Major Bleeding(1 year)
- Number of Participants With Usage of Concomitant Cardiac Medications(1 year)
- Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior(1 Year Pre and Post Index Procedure)
- Number of Participants With Device Embolization Requiring Surgery(1 year)
- Number of Participants With Device Embolization Not Requiring Surgery(1 year)
研究者
研究点 (6)
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