NL-OMON52896招募中不适用
REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure - RELIEVE-HF
V-Wave Ltd.- Olivia Mishall0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV
- •ejection fraction and documented heart failure for at least 6 months from
- •baseline visit.
- •2.NYHA Class II, Class III or ambulatory Class IV HF (historical assessment
- •documented at the Baseline Screening visit).
- •3. Receiving guideline directed medical therapy (GDMT) for heart failure which
- •refers to those HF drugs carrying a Class I indication:
- •a) Patients with reduced LVEF (<=40%): An inhibitor of the renin-angiotensin
- •system (RAS inhibitor), including an angiotensin-converting enzyme (ACE)
- •inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-
- •neprilysin inhibitor (ARNI) and a beta-blocker (BB), for at least 3 months
- •prior to the Baseline Visit.
- •b) Patients with reduced LVEF (<=40%): Other medications recommended for
- •selected populations, e.g., mineralocorticoid receptor antagonist (MRA) or
- •nitrates/hydralazine should be used in appropriate patients, according to the
- •published guidelines.
- •c) All patients: Patient has been on stable HF medications, as determined by
- •the investigator, for at least 1 month , with the exception of diuretic
- •therapy. Stable is defined as no more than a 100% increase or 50% decrease in
- •dose within these periods.
- •d) All patients: Drug intolerance, contraindications, or lack of indications
- •must be attested to by the investigator. Patients should be on appropriate
- •doses of diuretics as required for volume control.
- •4. Receiving Class I recommended cardiac rhythm management device therapy.
- •Specifically: if indicated by class I guidelines, cardiac resynchronization
- •therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should
- •be implanted at least 3 months prior to
- •Baseline Visit. These criteria may be waived if a patient is clinically
- •contraindicated for these therapies or refuses them and must be attested to by
- •the investigator.
- •5. NYHA Class II must meet both 5a AND 5b. NYHA Class III and ambulatory Class
- •IV must meet 5a OR 5b.
- •a) One (1) prior Heart Failure Hospitalization with duration >24 hours or
- •Emergency Room Heart Failure Visit with duration >=6 hours, or Heart Failure
- •Clinic ADHF Visit with duration >=6 hours, within 12 months from Baseline Visit.
- •i) If a CRT device was previously implanted, the heart failure hospitalization
- •must be >= 1 month after CRT implantation.
- •ii) If a mitral valve repair device (e.g. MitraClip) was previously implanted,
- •the heart failure hospitalization must be >= 1 month after mitral valve repair
- •implantation.
- •b) Alternatively, if patients have not had a HF hospitalization or ER HF Visit
- •within the prior 12 months, they must have a corrected elevated Brain
- •Natriuretic Peptide (BNP) level of at least 300 pg/ml or an N-terminal pro-BNP
- •(NT-proBNP) level of at least 1,500 pg/ml, according to local measurement,
- •within 3 months of the Baseline Visit during a clinically stable period and at
- •least 1 month after implantation of a CRT or mitral valve repair devices.
- •(Note: corrected refers to a 4% reduction in the BNP or NT-proBNP cutoff for
- •every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2). If patient
- •is on ARNI, NT-proBNP should be used exclusively.
- •6. Able to perform the 6-minute walk test with a distance >=100 meters and <=450
- 另有 1 项未显示
排除标准
- •1. Age <18 years old.
- •2. BMI >45 or <18 kg/m2.
- •3. Females of childbearing age who are not on contraceptives or surgically
- •sterile, pregnant or lactating mothers.
- •4. Resting systolic blood pressure <90 or >160 mmHg after repeated
- •measurements.
- •5. Baseline echocardiographic evidence of unresolved, non-organized or mobile
- •intracardiac thrombus.
- •6. Severe pulmonary hypertension defined as PA systolic pressure >70 mmHg by
- •echo/Doppler (or PVR >4.0 Wood Units by PA catheter measurement that cannot be
- •reduced to <=4 Wood Units by vasodilator therapy).
- •7. RV dysfunction defined as TAPSE <12mm or RVFAC <=25% as assessed on Baseline
- •8. Left Ventricular End-Diastolic Diameter (LVEDD) >8cm as assessed on Baseline
- •9. Atrial septal defect (congenital or iatrogenic), patent foramen ovale, or
- •anomalous pulmonary venous return, with more than trace shunting on color
- •Doppler or intravenous saline contrast (bubble study) or prior surgical or
- •interventional correction of congenital heart disease
- •involving the atrial septum (excluding closure by suture only but including
- •placement of a PFO or ASD closure device).
- •10. Untreated moderately severe or severe aortic or mitral stenosis.
- •11. Untreated severe or greater regurgitant valve lesions, which are
- •anticipated to require surgical or percutaneous intervention within 12 months.
- •12. Mitral valve repair device (e.g. MitraClip) implanted within 3 months prior
- •to Baseline Visit.
- •13. Untreated coronary stenosis which requires surgical or percutaneous
- •intervention.
- •14. Acute MI, acute coronary syndrome (ACS), percutaneous coronary intervention
- •(PCI), rhythm management system revision,(not including generator change) lead
- •extraction, or cardiac or other major surgery within 3 months of baseline
- •visit. Rhythm management system generator change within 1 month of Baseline
- •15. Known active valvular vegetations, atrial myxoma, hypertrophic
- •cardiomyopathy with significant resting or provoked subaortic gradient, acute
- •myocarditis, tamponade, or large pericardial effusion,
- •constrictive pericarditis, infiltrative cardiomyopathy (including cardiac
- •sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as
- •cause of HF.
- •16. Stroke, transient ischemic attack (TIA), systemic or pulmonary
- •thromboembolism, or deep vein thrombosis (DVT) within 6 months of Baseline
- •Visit. Any prior stroke with permanent neurologic deficit. Existing IVC
- •17. Transseptal procedure for another indication (e.g. AF ablation, left atrial
- •appendage occlusion, mitral valve repair/replacement) anticipated within 6
- •18. Bradycardia with heart rate <45 bpm (unless treated with a permanent
- •pacemaker) or uncontrolled tachyarrhythmias. This includes defibrillation
- •shocks reported by the patient within 30 days from baseline visit.
- •19. Intractable HF with:
- •a) Resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D).
- •b) Treatment with IV vasoactive medications (e.g., IV inotropes, IV
- •vasodilators) within the last 30 days.
- •c) Cardiac Index <1.5 L/min/m2.
- •d) Treated with a ventricular assist device (VAD).
- 另有 4 项未显示
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