A Prospective, Non-randomized, Multi-center Trial to Evaluate the Safety and Effectiveness of the HAART Model 300 Annuloplasty Ring When Used to Surgically Repair a Leaking Aortic Valve Using a 3-D Intra-annular Mounting Frame
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
研究概览
简要总结
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame
详细描述
Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations.
Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is 50 years old or older
- •The subject has a tricuspid aortic valve morphology
- •Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis
- •Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets
- •Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms
- •Patients who are free of coronary disease or those with evidence of minor stable (1-2 vessel) coronary disease
- •Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
- •The subject has signed the written informed consent
- •The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
- •The subject is New York Hospital Association (NYHA) class II or III
排除标准
- •The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position
- •The subject requires an additional valve replacement
- •The subject's aortic valve morphology is not tricuspid
- •The subject has active endocarditis
- •Heavily calcified valves
- •Valvular retraction with severely reduced mobility
- •The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
- •The subject requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device
- •Leukopenia
- •Acute anemia (Hb < 9mg%)
- •Platelet count <100,000 cell/mm3
- •Need for emergency surgery for any reason
- •History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions
- •Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)
- •Subjects in whom transesophageal echocardiography (TEE) is contraindicated
- •Non elective presentation
- •Low Ejection Fraction (EF) EF < 40%
- •Life expectancy < 1 year
- •Rheumatic disease
- •The subject has severe leaflet fenestration or leaflets damaged by endocarditis
- •The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
- •The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
- •The subject is pregnant or lactating
- •This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up
- •The subject has not signed and dated the study informed consent
- •Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •Myocardial infarction (MI) within one month of trial inclusion
- •Have a known intolerance to titanium or polyester
- •Sole therapy for correction for patients with aortic root aneurysm
- •Subjects requiring simultaneous cardiac procedures
- •The subject has asymptomatic AR and a left ventricular ejection fraction (LVEF) > 50%
结局指标
主要结局
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
时间窗: 2 years postprocedure (extended follow-up)
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
时间窗: 6 months postprocedure
Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Primary Safety Outcome Measure: Event-free Survival
时间窗: 2 years postprocedure (extended follow-up)
Event-free survival is defined as survival free from device-related death
次要结局
- Event-free Survival(6 months postprocedure)
- LVID Systole - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LV Diastolic Volume - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- New York Heart Association (NYHA) Functional Capacity Classification(2 years postprocedure (extended follow-up))
- Peak Gradient - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Mean Gradient - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Implant Procedure Success(2 years postprocedure (extended follow-up))
- Actuarial Freedom From Clinical Cardiovascular Events(2 years postprocedure)
- LVID Diastole - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LV Mass - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LV Systolic Volume - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- LVEF - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Cardiac Output - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))
- Cardiac Index - Change From Baseline(Baseline, 2 years postprocedure (extended follow-up))