A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
研究概览
简要总结
The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.
详细描述
The MitraClip System ANZ Clinical Trial is a prospective, observational, single arm, multicenter trial to evaluate the MitraClip device for the treatment of mitral regurgitation (MR). Patients will be enrolled at up to 15 investigational sites throughout Australia and New Zealand. Up to 150 patients will be enrolled. Patients will be considered enrolled when local or general anesthesia is administered for the MitraClip procedure. Patients will be followed at discharge, 30 days, 6 months, 12 months and 24 months.
Investigational sites will recruit consecutive patients who meet trial enrollment criteria. Until enrollment in the MitraClip System ANZ Clinical Trial is closed, all patients who undergo a procedure for placement of a MitraClip device at an investigational site should be enrolled in the MitraClip System ANZ Clinical Trial.
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
- •Age 18 years or older.
- •MR ≥ 3+ .
- •Transseptal catheterization and femoral vein access feasible.
- •Placement of the MitraClip device on mitral leaflets feasible.
- •Mitral valve orifice area ≥ 4.0 cm
- •Written informed consent obtained.
- •The patient agrees to return for follow-up visits.
排除标准
- •Need for emergency surgery, other cardiac surgery.
- •Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
- •Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
- •Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
- •Transesophageal echocardiography (TEE) contraindicated.
- •Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
- •Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
- •Pregnant or planning pregnancy within next 12 months.
结局指标
主要结局
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
时间窗: 12 months
Clinical Endpoint. * Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) * Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
次要结局
- Left Ventricle End Diastolic Volume (LVEDV)(At Baseline and 12 months)
- Left Ventricular End Systolic Volume (LVESV)(At Baseline and 12 months)
- Left Ventricular Ejection Fraction (LVEF)(At Baseline and 12 months)
- Number of Participants With MR Severity(12 months)
- Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted(Day 0 (On the day of procedure))
- Number of Participants With Acute Procedural Success Rate(At day 0 (on the day of index procedure))
- Total Contrast Volume(At day 0 (on the day of index procedure))
- Left Ventricular Internal Diameter End Systole (LVIDs)(At Baseline and 12 Months)
- Regurgitant Volume(At Baseline and 12 Months)
- Number of Participants at Discharge Facility(< or = 12 days)
- Rate of Patients Rehospitalized(30 days)
- Device Time(At day 0 (on the day of index procedure))
- Fluoroscopy Duration(At day 0 (on the day of index procedure))
- Left Ventricular Internal Diameter End Diastole (LVIDd)(At Baseline and 12 Months)
- Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)(12 months)
- Number of Participants With Second Intervention to Place an Additional MitraClip Device(Through 12 months)
- Duration of Rehospitalization(30 days)
- Post-procedure Hospital Stay(Post index procedure within 30 days)
- Procedure Time(At day 0 (on the day of index procedure))
- Mitral Valve Area (MVA) by Pressure Half-time (PHT)(At Baseline and 12 Months)
- Mitral Valve Mean Gradient(At Baseline and 12 Months)
- Six Minute Walking Distance(12 months)
- Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months(12 months)
- Regurgitant Fraction(At Baseline and 12 Months)
- Percentage of Participants With New York Heart Association (NYHA) Class(12 months)
- Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months(6 months)
- Number of Participants With Mitral Valve Surgery(30 days of Post-MitraClip Procedure)
- Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration(Post index procedure within 30 days)
- Left Atrial Volume(At Baseline and 12 Months)
- Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days(30 days)