NL-OMON55735已完成不适用
REDUCE LAP-HF RANDOMIZED TRIAL II: 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 RANDOMIZED TRIAL II:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
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. Symptoms of HF requiring current treatment with diuretics for >= 30 days and
- •b. New York Heart Association (NYHA) class II if a prior history of > NYHA
- •class II; or NYHA class III, or ambulatory NYHA 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
- •c. >= 1 HF hospital admission (with HF as the primary, or secondary diagnosis);
- •or treatment with intravenous (IV), or the need for intensification of oral
- •diuresis for HF in a healthcare 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.
- •2. Ongoing stable GDMT HF management and management of potential comorbidities
- •according to the 2017 ACC/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 enrollment which is
- •expected to be maintained for 6 months.Stable management includes a minimum
- •period of 4 weeks post hospitalization for any cause, including treatment with
- •IV diuretics.
- •3. Age >= 40 years old
- •4. Site determined echocardiographic LV ejection fraction >=40% within the past
- •6 months, without documented ejection fraction <30% in the 5 years prior to
- •study entry.
- •5. Site determined elevated PCWP with a gradient compared to right atrial
- •pressure (RAP) documented by:
- •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. Diastolic LA volume > 50, or 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 to the right atrium is
- •determined to be feasible by site interventional cardiology investigator.
排除标准
- •1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in
- •past 3 months, or current indication for coronary revascularization; AVR
- •(surgical AVR or TAVR) within the past 12 months or a planned cardiac
- •interventions in the 3 months following enrollment.
- •2. Cardiac resynchronization therapy initiated within the past 6 months
- •3. Advanced 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) for EF < 40% within the past
- •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. The patient has verified that the ability to walk 6 minutes is limited
- •primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or
- •lifestyle and not by shortness of breath and/or fatigue and/or chest pain.
- •6. Unwilling or unable (per PhysIQ protocol) to wear telemonitoring patch,
- •unless cell-phone based monitoring device is not available in that region
- •7. Known clinically significant un-revascularized coronary artery disease,
- •defined as: epi-cardial coronary artery stenosis with angina or other evidence
- •of ongoing active coronary ischemia.
- •8. History of stroke, transient ischemic attack (TIA), deep vein thrombosis
- •(DVT), or pulmonary emboli within the past 6 months
- •9. Known clinically significant untreated carotid artery stenosis likely to
- •require intervention.
- •10. Presence of hemodynamically significant valve disease assessed by the site
- •cardiologist and defined as:
- •a. Mitral valve disease defined as grade >= 3+ MR or > mild MS OR
- •b. Tricuspid valve regurgitation defined as grade >= 2+ TR OR
- •c. Aortic valve disease defined as >= 2+ AR or > moderate AS
- •11. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy,
- •constrictive pericarditis, cardiac amyloidosis or other infiltrative
- •cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
- •12. Subject is contraindicated to receive either dual antiplatelet therapy or
- •an oral anticoagulant;); or has a documented coagulopathy
- •13. Atrial fibrillation with resting HR > 100 BPM
- •14. Resting arterial oxygen saturation < 95% on room air
- •15. Significant hepatic impairment defined as 3X upper limit of normal of
- •transaminases, total bilirubin, or alkaline phosphatase
- •16. Right ventricular dysfunction, assessed by the site cardiologist and
- •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. Ultrasound or clinical evidence of congestive hepatopathy; OR
- •e. Evidence of RV dysfunction defined by TTE as an RV fractional area change <
- •17. Resting RAP > 14 mmHg
- •18. Evidence of significant pulmonary hypertension defined as PVR > 3.5 Wood
- •units at rest or peak exercise
- •19. Chronic pulmonary disease requiring continuous home oxygen, OR significant
- •chronic pulmonary disease defined as FEV1 <1L.
- •20. Hemoglobin <10 g/dl
- 另有 4 项未显示
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