NCT04965623撤回不适用
ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)
Edwards Lifesciences0 个研究点目标入组 15 人开始时间: 2021年2月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 15
- 主要终点
- Rate of Safety Events (MACCREE, Re-Intervention)
研究概览
简要总结
The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.
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
- •Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
- •≥ 18 years old
- •Chronic symptomatic Heart Failure (HF) documented by the following:
- •NYHA class III or ambulatory NYHA class IV within last 12 months AND
- •≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility) within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
- •In the judgment of the investigator, subject is on stable Guideline Directed Medical Therapy (GDMT) for heart failure and management of potential comorbidities according to current ACCF/AHA/ESC Guidelines and that is expected to be maintained without change for 3 months
- •Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine ergometer exercise stress test as measured at end-expiration
- •Willing to attend study follow-up assessments for up to 5 years
排除标准
- •Severe heart failure defined as one or more of the below:
- •ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
- •If BMI < 30, Cardiac index < 2.0 L/min/m2
- •If BMI ≥ 30, cardiac index < 1.8 L/min/m2
- •Inotropic infusion (continuous or intermittent) within the past 6 months
- •Patient is on the cardiac transplant waiting list
- •LVEF < 20%
- •Presence of significant valve disease defined by the site cardiologist as:
- •Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS
- •Tricuspid valve regurgitation defined as grade > 2+ TR
- •Aortic valve disease defined as > 2+ AR or > moderate AS
- •MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization
- •Valve replacement or surgical annuloplasty within the past 12 months
- •Stroke or transient ischemic attack (TIA) within the past 6 months
- •Hemodynamic instability within 30 days of scheduled implant procedure
- •Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure
- •Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis) at the time of screening per central screening committee
- •Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
- •Significant hepatic impairment defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
- •Right ventricular dysfunction, defined by the site cardiologist as:
- •More than mild RV dysfunction as estimated by TTE; OR
- •TAPSE <1.4 cm; OR
- •RV size ≥ LV size as estimated by TTE; OR
- •Echocardiographic or clinical evidence of congestive hepatopathy;
- •Evidence of pulmonary hypertension with PVR >4 Wood units
- •Performance of the 6 minute walk test with a distance <50m OR >600m
- •Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy
- •Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
- •Known hypersensitivity to Nickel and/or Tantalum
- •In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons
- •In the opinion of the investigator and Central Screening Committee, the subject is not an appropriate candidate for the study
- •Anatomy or implantable device that is not compatible with or could potentially interfere with the Edwards Transcatheter Atrial Shunt System as determined by the Investigator and Central Screening Committee
- •Active endocarditis or infection within 3 months of scheduled implant procedure
- •Currently participating (e.g., undergoing trial specific exams/treatment/procedures) in an investigational drug or device study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational trials.
- •Patient is a current intravenous drug user
- •Positive serum pregnancy test in female subjects of child-bearing potential or nursing mothers or planning on becoming pregnant during the duration of the trial
- •Patient is under guardianship
- •Known pre-existing shunting, determined to be clinically significant by the investigator and Central Screening Committee
- •Patients with a CRT lead in the coronary sinus
研究组 & 干预措施
Edwards Transcatheter Atrial Shunt System
Experimental
Edwards Transcatheter Atrial Shunt System
干预措施: Atrial Shunt (Device)
结局指标
主要结局
Rate of Safety Events (MACCREE, Re-Intervention)
时间窗: 30 Days
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
次要结局
- Change in PCWP(Baseline, 3 months, 6 months)
- Rate of Device Success(Day 0)
- Rate of Procedural Success(10 Days post-op)
- Change in Qp/Qs(Baseline, 3 months, 6 months)
研究者
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