NL-OMON45159已完成不适用
A study to evaluate the DC Devices, Inc. IASD* System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure - REDUCE LAP-HF TRIA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Candidates for the study must meet ALL of the following inclusion criteria:
- •1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- •a. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
- •b. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
- •c. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
- •2. Age * 40 years old
- •3. Left ventricular ejection fraction (obtained by echocardiography) * 40%
- •4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
- •a. PCWP (end expiratory) or LVEDP (end expiratory) at rest * 15 mmHg, and greater than CVP, OR
- •b. PCWP (end expiratory) during supine bike exercise * 25mm Hg, and CVP < 20 mm Hg
- •5. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC
- •6. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
- •7. Trans-septal catheterization and femoral vein access is determined to be feasible
排除标准
- •Candidates for this study will be excluded if ANY of the following conditions are present:
- •1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
- •2. Cardiac Resynchronization Therapy initiated within the past 6 months
- •3. Severe heart failure defined as:
- •a. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
- •b. Cardiac Index < 2.0 L/min/m2
- •c. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
- •d. Patient is on the cardiac transplant waiting list
- •4. Inability to perform 6 Minute Walk Test
- •5. Known significant coronary artery disease (stenosis >70%)
- •6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
- •7. Known severe carotid artery stenosis (> 70%)
- •8. Presence of significant valve disease defined by echocardiography as:
- •a) Mitral valve regurgitation defined as grade >2+ MR
- •b) Tricuspid valve regurgitation defined as grade * 2+ TR;
- •c) Aortic valve disease defined as * 2+ AR or moderate AS
- •9. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac Amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, Sarcoidosis)
- •10. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin analogue; or has a documented coagulopathy
- •11. Atrial fibrillation with resting HR > 100 BPM
- •12. Arterial Oxygen saturation < 95% on room air
- •13. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
- •14. Right ventricular dysfunction, defined as
- •a. More than mild RV dysfunction as determined by TTE: OR
- •b. TAPSE < 1.4 cm: OR
- •c. RV volume * LV volume on echo estimate; OR
- •d. Echocardiographic or clinical evidence of congestive hepatopathy
- •15. Resting CVP > 14 mmHg
- •16. Evidence of pulmonary hypertension with PVR > 4 Woods Units (mm Hg/L/min)
- •17. Chronic pulmonary disease requiring home oxygen, OR hospitalization for exacerbation in the 6 months prior to study entry, OR significant chronic pulmonary disease defined either as FEV1 <1, or in the opinion of the investigator
- •18. Currently participating 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
- •19. Life expectancy less than 12 months for non-cardiovascular reasons
- •20. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
- •21. Known or suspected allergy to nickel
- •22. Fertile women
- •23. Currently requiring dialysis; or e-GFR <25ml/min
- •24. SABP >170 despite appropriate medical management
- •25. Subjects in whom trans-esophageal echocardiography (TEE) is contraindicated
- •26. Subjects with existing Atrial Septal Defects. Subjects with a Patent Foramen Ovale (PFO), who have elevated filling pressure despite the PFO are allowed.
- •27. Subjects on immunosuppression or systemic steroid treatment (>10 mg prednisone/day)
- •28. Subjects who have diagnosed scleroderma
- •29. In the opinion of the investigator, the subject is not an appropriate candidate for the study
研究者
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