NCT07057323Enrolling By Invitation不适用
Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure With A Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, specifically invasive measurement of PAWP during standardized exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent and willing to participate in all required study follow-up assessments
- •Clinical indicated coronary angiography with invasive CRT testing or PET with CRF assessment prior to enrollment. Abnormal CFR of ≤ 2.5 or PET CFR ≤ 2.0
- •Symptomatic HFpEF defined by (PAWP>15mmHg at rest and /or PAWP>25 mmHg on exertion) during clinically performed Right heat catheterization with exercise performed prior to enrollment or during screening visit (if not performed clinically ).
- •Non-Obstructive CAD (≤ 50% stenosis in epicardial vessels and/or iFR>0.89 or FFR>0.8 in vessels with 50 to 70% stenosis)
排除标准
- •Significant epicardial CAD (angiographic stenosis ≥70% or positive FFR or iFR in any major epicardial coronary artery
- •Significant valvular heart disease moderate to severe regurgitation and or stenosis)
- •Primary cardiomyopathies (hypertrophic, infiltrative or restrictive)
- •Constrictive pericarditis
- •Severe myocardial bridging
- •Pregnancy
- •Recent (with 3 months) acute coronary syndrome
- •Subjects in Cardiogenic shock (systolic pressure<80mm/Hg)
- •Mean right atrial pressure at rest >15 mmHg
- •Anomalous or abnormal CS anatomy (e.g. tortuosity aberrant branch persistent left superior vena cava as demonstrated on angiogram
- •CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram.
- •Known severe reaction to required procedural medications
- •Known allergy to stainless steel or nickel
- •Magnetic Resonance Imaging (MRI) within 8 weeks after Reducer implantation
- •Chronic renal failure (serum creatinine>2mg/dL)
- •Severe chronic obstructive pulmonary disease (COPD) as indicated by forced expiratory volume in one second that is less than 55% of the predicted value or need for home daytime oxygen
- •Pacemaker electrode/lead in the coronary sinus
- •Moribund or with comorbidities limiting life expectancy to less than one year
- •Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
- •Inability or unwillingness of individual to give written informed consent.
- •Additional factors deemed unsuitable for trial enrollment per discretion of the Principal Investigator
研究组 & 干预措施
Heart failure with a preserved ejection fraction (HFpEF)
Experimental
Subjects with diagnosed Heart failure with a preserved ejection fraction (HFpEF), non-obstructive Coronary Artery Disease (CAD), and have documented CMD.
干预措施: Coronary Sinus Reducer (Device)
结局指标
主要结局
Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise
时间窗: Baseline, 6 months
Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at 20W exercise.
Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise
时间窗: Baseline, 6 months
Pulmonary Arterial Wedge Pressure (mmHg) is a measure of cardiac filling pressure. PAWP will be determined by a right heart catheterization at 20W exercise.
次要结局
- Change in Kansas City Cardiomyopathy (KCCQ-12)(Baseline, 30 Days, 60 Days, 90 Days, 6 months)
- Change in Seattle Angina Questionnaire (SAQ)(Baseline, 30 Days, 60 Days, 90 Days, 6 months)
- Change in New York Heart Association (NYHA) classification(Baseline, 6 months)
- Change in Canadian Cardiovascular Society (CCS)(Baseline, 30 Days, 60 Days, 90 Days, 6 months)
- Change in Borg maximal perceived exertion scores(Baseline, 6 months)
- Change in maximum exercise capacity (VO2 max) during supine exercise testing(Baseline, 6 months)
- Change in transcardiac lactate release(Baseline, 6 months)
- Change in transcardiac lactate uptake(Baseline, 6 months)
- Change in Pulmonary Arterial Wedge Pressure (PAWP) at rest(Baseline, 6 months)
- Change in Pulmonary Arterial Pressure at rest(Baseline, 6 months)
- Change in Pulmonary Arterial Pressure at exercise(Baseline, 6 months)
- Cardiac output(Baseline, 6 months)
- Change in Right Atrial Pressure(Baseline, 6 months)
- Change in Pulmonary Arterial Pressure at exercise(Baseline, 6 months)
- Change in Right Atrial Pressure(Baseline, 6 months)
- Change in Kansas City Cardiomyopathy (KCCQ-12)(Baseline, 30 Days, 60 Days, 90 Days, 6 months)
- Change in Seattle Angina Questionnaire (SAQ)(Baseline, 30 Days, 60 Days, 90 Days, 6 months)
- Change in New York Heart Association (NYHA) classification(Baseline, 6 months)
- Change in Canadian Cardiovascular Society (CCS)(Baseline, 30 Days, 60 Days, 90 Days, 6 months)
- Change in Borg maximal perceived exertion scores(Baseline, 6 months)
- Change in maximum exercise capacity (VO2 max) during supine exercise testing(Baseline, 6 months)
- Change in transcardiac lactate release(Baseline, 6 months)
- Change in transcardiac lactate uptake(Baseline, 6 months)
研究者
Claire E. Raphael
Principal Investigator
Mayo Clinic
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina IIRefractory AnginaNCT05102019Shockwave Medical, Inc.380
招募中
不适用
Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for RevascularizationRefractory AnginaNCT01566175Tel-Aviv Sourasky Medical Center100
招募中
不适用
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial IschemiaCoronary Artery DiseaseAngina PectorisNCT06266065Clinical Hospital Centre Zagreb25
进行中（未招募）
不适用
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.Refractory AnginaMicrovascular AnginaMicrovascular Coronary Artery DiseaseCoronary DiseaseINOCA (Ischemia With Non Obstructive Coronary Artery Disease)ANOCA - Angina With Non-obstructive Coronary ArteriesCoronary Microvascular Dysfunction (CMD)Angina PectorisNCT05492110Imperial College London54
Enrolling By Invitation
不适用
Coronary Sinus Reducer in Coronary Microvascular DiseaseNCT06898541UMC Utrecht50