ACTRN12619000602123尚未招募未知
A Pilot Study to Assess the Safety, Hemodynamic and Electrophysiologic Effect of Left Atrial Decompression by an InterAtrial Shunt Device (IASD) in Patients Undergoing Pulmonary Vein Isolation with atrial fibrillation
Corvia Medical0 个研究点目标入组 20 人开始时间: 2019年4月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients undergoing repeat pulmonary vein isolation for atrial fibrillation (as directed by the Electrophysiology Service in the Alfred Hospital, Cardiology Department)
- •2. Subject aged above 40 years
- •3. Symptoms of exertional breathlessness (NYHA III-III)
- •4. Echocardiographic or MRI evidence for LV ejection fraction equals 40% within the past 6 months
- •5. Echocardiographic or MRI evidence for left atrial enlargement (Left Atrial Volume Index >34 mL/m sq)
- •6. Qualifying hemodynamics (performed within 60 days prior to PVI), including:
- •a. End-expiratory resting PCWP equals 18 mm Hg, and greater than RAP by and electrophysiologic 5 mm Hg; OR
- •b. End-expiratory exercise PCWP above 25mm Hg, and greater than RAP by and electrophysiologic 5 mm Hg.
- •7. Anticoagulation
- •8. Subject provides written informed consent
- •The IASD will be implanted if all inclusion/exclusion criteria have been met AND the PVI procedure has been completed successfully and without complication
排除标准
- •Candidates for this study will be excluded if any of the following are present:
- •1. Cardiac surgery (including CABG, valve replacement) in the past 12 months
- •2. Acute coronary syndrome or MI in the past 3 months
- •3. NYHA Class IV heart failure symptoms
- •4. Significant valvular heart disease:
- •a. Mitral valve disease defined as grade equals 3+ MR or above mild MS
- •b. Tricuspid valve regurgitation defined as grade equals 2+ TR;
- •c. Aortic valve disease defined as equals 2+ AR or above moderate AS
- •5. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
- •6. Evidence of right ventricular dysfunction including one or more of: >mild RV dysfunction (visually), RV FAC<35% or TAPSE <1.4cm
- •7. Any life limiting condition with a life expectancy of <2 years
- •8. Evidence of significant renal or hepatic dysfunction defined as eGFR<30 umol/L or hepatic transaminase 3x ULN.
- •9. Resting right atrial pressure > 14 mmHg
- •10. Evidence of significant pulmonary hypertension defined as PVR > 3.5 Wood units
- •11. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 above 1L.
- •12. Hemoglobin above 10 g/dl
- •13. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- •14. Known or suspected allergy to nickel
- •15. Fertile women
- •16. Systolic blood pressure above 170 mm Hg.
- •17. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (above 10 mg prednisone per day).
研究者
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