Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure

Официальное название

Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure With A Preserved Ejection Fraction Associated With Coronary Microvascular Dysfunction

Обзор

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.

Вмешательства

• Устройство Coronary Sinus Reducer
  Subjects will have the Coronary Sinus Reducer implanted in their coronary sinus during a right heart catheterization procedure.

Первичные конечные точки

• Change in Pulmonary Arterial Wedge Pressure (PAWP) at exercise [Срок оценки: Baseline, 6 months]

Вторичные конечные точки (12)

• Change in Kansas City Cardiomyopathy (KCCQ-12) [Срок оценки: Baseline, 30 Days, 60 Days, 90 Days, 6 months]
• Change in Seattle Angina Questionnaire (SAQ) [Срок оценки: Baseline, 30 Days, 60 Days, 90 Days, 6 months]
• Change in New York Heart Association (NYHA) classification [Срок оценки: Baseline, 6 months]
• Change in Canadian Cardiovascular Society (CCS) [Срок оценки: Baseline, 30 Days, 60 Days, 90 Days, 6 months]
• Change in Borg maximal perceived exertion scores [Срок оценки: Baseline, 6 months]
• Change in maximum exercise capacity (VO2 max) during supine exercise testing [Срок оценки: Baseline, 6 months]
• Change in transcardiac lactate release [Срок оценки: Baseline, 6 months]
• Change in transcardiac lactate uptake [Срок оценки: Baseline, 6 months]
• Change in Pulmonary Arterial Wedge Pressure (PAWP) at rest [Срок оценки: Baseline, 6 months]
• Change in Pulmonary Arterial Pressure at rest [Срок оценки: Baseline, 6 months]
• Change in Pulmonary Arterial Pressure at exercise [Срок оценки: Baseline, 6 months]
• Cardiac output [Срок оценки: Baseline, 6 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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
• Inmates

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07057323 · 25-002292

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗