A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Mitral Regurgitation Severity
研究概览
简要总结
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
详细描述
Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System.
The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month clinical follow-up.
Up to 12 clinical sites throughout the US may participate.
The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of reduction of MR.
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
- •Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction;
- •Experience regurgitation origination from the central two-thirds of the valve;
- •Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass.
排除标准
- •Ejection fraction < 30%
- •Endocarditis
- •Rheumatic heart disease
- •Renal insufficiency
研究组 & 干预措施
MitraClip
Percutaneous mitral valve repair (MitraClip Implant)
干预措施: Percutaneous mitral valve repair (MitraClip Implant) (Device)
结局指标
主要结局
Mitral Regurgitation Severity
时间窗: At 5 years
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Major Adverse Events (MAE)
时间窗: Through 6 Months
Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.
Mitral Regurgitation Severity
时间窗: At baseline
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
时间窗: At discharge or within 30 days of the procedure
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
时间窗: At 12 months
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
时间窗: At 24 months
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
时间窗: At 3 years
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Mitral Regurgitation Severity
时间窗: At 4 years
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Major Adverse Events (MAE)
时间窗: Through 30 days
Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.
次要结局
- Number of Mitraclip Devices Implanted(At day 0 (on the day of index procedure))
- Second Intervention to Place a Second MitraClip Device(Post index procedure through 5 years)
- MitraClip Device Embolizations and Single Leaflet Device Attachment(Post index procedure through 5 years)
- Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)(At 5 Years)
- Death (Kaplan-Meier Freedom From Death)(At 5 years)
- Major Vascular and Bleeding Complications(Through 6 Months)
- Procedure Time(At day 0 (on the day of index procedure))
- Cardiac Output(60 months)
- Device Time(At day 0 (on the day of index procedure))
- Fluoroscopy Duration(At day 0 (on the day of index procedure))
- Contrast Volume(At day 0 (on the day of index procedure))
- Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration(Post index procedure within 30 days)
- Post-procedure Hospital Stay(Post-index procedure until hospital discharge (1 to 19 days))
- Left Ventricular End Diastolic Volume(60 months)
- Left Ventricular End Systolic Volume(60 months)
- Intra-procedural Major Adverse Events(At day 0 (on the day of index procedure))
- Other Secondary Safety Events(Through 6 months)
- Mitral Valve Gradient(60 months)
- New York Heart Association (NYHA) Functional Class(60 months)
- Mitral Valve Area - Single Orifice(60 months)
- Mitral Valve Area (MVA) by Pressure Half-Time(60 months)
- Cardiac Index(60 months)
- Death (Kaplan-Meier Freedom From Death)(At 4 years)
- Death (Kaplan-Meier Freedom From Death)(At 3 years)
- Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)(At baseline)
- Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)(At 12 months)
- Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)(At 24 months)
- Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)(At 3 Years)
- Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)(At 4 Years)
- Death (Kaplan-Meier Freedom From Death)(Within 30 days of the procedure)
- Death (Kaplan-Meier Freedom From Death)(At 12 months)
- Death (Kaplan-Meier Freedom From Death)(At 24 months)
- Major Vascular and Bleeding Complications(Through 30 days)
- Other Secondary Safety Events(Through 30 days)
- Left Ventricular End Diastolic Volume(Baseline)
- Left Ventricular End Diastolic Volume(During the hospital stay with a maximum of 3 days post index procedure (Discharge))
- Left Ventricular End Diastolic Volume(12 months)
- Left Ventricular End Diastolic Volume(24 months)
- Left Ventricular End Systolic Volume(Baseline)
- Left Ventricular End Systolic Volume(During the hospital stay with a maximum of 3 days post index procedure (Discharge))
- Left Ventricular End Systolic Volume(12 months)
- Cardiac Output(Baseline)
- Left Ventricular End Systolic Volume(24 months)
- Mitral Valve Area - Single Orifice(Baseline)
- Mitral Valve Area - Single Orifice(During the hospital stay with a maximum of 3 days post index procedure (Discharge))
- Mitral Valve Area - Single Orifice(12 months)
- Cardiac Output(During the hospital stay with a maximum of 3 days post index procedure (Discharge))
- Mitral Valve Area - Single Orifice(24 months)
- Mitral Valve Area (MVA) by Pressure Half-Time(Baseline)
- Mitral Valve Area (MVA) by Pressure Half-Time(During the hospital stay with a maximum of 3 days post index procedure (Discharge))
- Mitral Valve Area (MVA) by Pressure Half-Time(12 months)
- Mitral Valve Area (MVA) by Pressure Half-Time(24 months)
- Mitral Valve Gradient(Baseline)
- Mitral Valve Gradient(During the hospital stay with a maximum of 3 days post index procedure (Discharge))
- Mitral Valve Gradient(12 months)
- Mitral Valve Gradient(24 months)
- Cardiac Output(12 months)
- Cardiac Output(24 months)
- Cardiac Index(Baseline)
- Cardiac Index(During the hospital stay with a maximum of 3 days post index procedure (Discharge))
- Cardiac Index(12 months)
- Cardiac Index(24 months)
- New York Heart Association (NYHA) Functional Class(Baseline)
- New York Heart Association (NYHA) Functional Class(6 months)
- New York Heart Association (NYHA) Functional Class(30 days)
- New York Heart Association (NYHA) Functional Class(12 months)
- New York Heart Association (NYHA) Functional Class(18 months)
- New York Heart Association (NYHA) Functional Class(24 months)
- New York Heart Association (NYHA) Functional Class(36 months)
- New York Heart Association (NYHA) Functional Class(48 months)