NL-OMON53718招募中不适用
Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure - RESPONDER-HF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 if tolerated for >=
- •30 days AND
- •b. New York Heart Association (NYHA) class II with prior history of >class II;
- •OR NYHA class III, or ambulatory
- •NYHA class IV symptoms; AND
- •c. >= 1 HF hospital admission (with HF as the primary, or secondary diagnosis);
- •or treatment with intravenous (IV) diuretics; or intensification of oral
- •diuresis 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 comorbidities according
- •to the 2022 ACC/AHA Guidelines for the Management of Heart Failure. Stable
- •management includes a minimum period of 4 weeks post-hospitalization for any
- •cause, including treatment with IV diuretics.
- •3. Site determined echocardiographic LV ejection fraction >= 40% within the past
- •6 months, without documented ejection fraction < 30% in the 5 years prior.
- •4. 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/m 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
- •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. Resting RAP <= 14 mmHg
- •7. Site determined hemodynamic evidence of peak exercise PVR < 1.75 Wood units
- •inclusion criterion]
- •8. Age >= 40 years old
- •9. Participant 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
- •10. Participant is willing to comply with clinical investigation procedures and
- •agrees to return for all required follow-up visits, tests, and exams
- •11. Transseptal catheterization and femoral vein access to the right atrium is
- •determined to be feasible by site interventional cardiology investigator.
排除标准
- •1. 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.
- •2. Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk
- •test > 600m
- •3. 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).
- •4. Right ventricular dysfunction, assessed by the site cardiologist and defined
- •as one or more of the following:
- •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 <
- •5. Any implanted cardiac rhythm device [NEW exclusion criterion]
- •6. Structural heart repair AVR or MVR (surgical or percutaneous) within the
- •past 12 months; planned valve intervention in the next 3 months, or presence
- •of hemodynamically significant valve disease as assessed by the site
- •cardiologist and defined as:
- •a. Mitral valve disease grade >= 3+ MR or > mild MS; OR
- •b. Tricuspid valve regurgitation grade >= 2+ TR; OR
- •c. Aortic valve disease >= 2+ AR or > moderate AS.
- •7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- •8. Participants with existing or surgically closed (with a patch) atrial septal
- •Participants with a patent foramen ovale (PFO), who meet PCWP criteria despite
- •the PFO, are not excluded.
- •9. MI and/or percutaneous cardiac intervention within past 3 months; CABG in
- •past 3 months or any planned cardiac interventions in the 3 months following
- •enrollment.
- •10. Known clinically significant un-revascularized coronary artery disease,
- •defined as:
- •coronary artery stenosis with angina or other evidence of ongoing active
- •coronary ischemia.
- •11. Known clinically significant untreated carotid artery stenosis likely to
- •require intervention.
- •12. Atrial fibrillation with resting HR > 100 BPM
- •13. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy,
- •constrictive pericarditis, cardiac amyloidosis or infiltrative cardiomyopathy
- •(e.g. hemochromatosis sarcoidosis)
- •14. History of stroke, transient ischemic attack (TIA), deep vein thrombosis
- •(DVT), or pulmonary emboli within the past 6 months.
- •15. Participant is contraindicated to receive either dual antiplatelet therapy,
- •or an oral anticoagulant; or has a documented coagulopathy
- •16. Anemia with Hemoglobin < 10 g/dl
- •17. Chronic pulmonary disease requiring continuous home oxygen, OR significant
- •chronic pulmonary disease defined as FEV1 <1L.
- •18. Resting arterial oxygen saturation < 95% on room air, <93% when residing at
- 另有 7 项未显示
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