NL-OMON42917已完成不适用
REDUCE LAP-HF Dutch RANDOMIZED TRIAL I: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure - REDUCE LAP-HF Dutch RANDOMIZED TRIAL I
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
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
- •1. Chronic symptomatic heart failure (HF) documented by the following:
- •a. New York Heart Association (NYHA) class 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; AND
- •b. >= One hospital admission for which HF was a major component of the hospitalization, or a healthcare facility (emergency department/acute care facility) treatment with intravenous (IV) or intensification of oral diuresis for HF, within the 12 months prior to study entry; OR an NT-pro BNP value > 200 pg/ml in normal sinus rhythm, > 600 pg/ml in atrial fibrillation, or a BNP value > 70 pg/ml in normal sinus rhythm, > 200 pg/ml in atrial fibrillation within the past 6 months.
- •2. Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose changes for a minimum of 4 weeks prior to screening) that is expected to be maintained without change for 6 months.
- •3. Age >= 40 years old
- •4. Site determined LV ejection fraction >= 40% within the past 3 months, without previously documented ejection fraction <30%.% (within the last 5 years).
- •5. Site determined elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by:
- •a. End-expiratory PCWP during supine ergometer exercise >= 25mm Hg, and greater than RAP by >= 5 mm Hg.
- •6. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
- •a. LA diameter > 4 cm; or
- •b. LA volume index > 28 ml/m2 or
- •c. Lateral e* <10 cm/s; or
- •d. Septal e* <8 cm/s; or
- •e. Lateral E/e* >10 ; or
- •f. Septal E/e* > 15
- •7. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB or EC
- •8. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
- •9. Trans-septal catheterization and femoral vein access is determined to be feasible by site principal interventional cardiology investigator
排除标准
- •1. Myocardial infarction 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 one or more of the below:
- •a. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
- •b. Cardiac index < 2.0 L/min/m2
- •c. 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 (distance < 50 m), OR 6 minute walk test > 600m
- •5. Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
- •6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
- •7. Known clinically significant untreated carotid artery stenosis.
- •8. Presence of significant valve disease defined by the site cardiologist as:
- •a) Mitral valve regurgitation defined as grade >= 3+ MR
- •b) Tricuspid valve regurgitation defined as grade >= 2+ TR;
- •c) Aortic valve disease defined as >= 2+ AR or > moderate AS
- •9. Hypertrophic obstructive 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 by the site cardiologist as
- •a. More than mild RV dysfunction as estimated by TTE; OR
- •b. TAPSE < 1.4 cm; OR
- •c. RV size >= LV size as estimated by TTE; OR
- •d. Echocardiographic or clinical evidence of congestive hepatopathy; OR
- •e. Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%;
- •15. Resting RAP > 14 mmHg
- •16. Evidence of pulmonary hypertension with PVR > 4 Wood units
- •17. Chronic pulmonary disease requiring continuous home oxygen, OR hospitalization for exacerbation in the 12 months prior to study entry, OR significant chronic pulmonary disease defined as FEV1 < 50% predicted, 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 estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
- •24. Systolic blood pressure >170 mm Hg at screening
- •25. Subjects with existing atrial septal defects. Subjects with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are allowed.
- •26. Subjects on immunosuppression or systemic steroid treatment (>10 mg prednisone/day).
- •27. Severe obstruct
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