Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation

Официальное название

Prospective, Multi-Center, Single-Arm Study: Safety and Technical Feasibility of the Tangent Tricuspid Annular Therapy System for Transcatheter Valve Repair in Patients With Severe, Symptomatic Functional Tricuspid Regurgitation

Обзор

The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.

Вмешательства

• Устройство Tricuspid Annular Therapy System
  A transcatheter device designed for tricuspid valve repair.

Первичные конечные точки

• Primary Safety Endpoint: Proportion of Patients Free From Device or Procedure-Related Major Adverse Events (MAEs) Through 30-Days Post-Procedure [Срок оценки: 30 days post-procedure]
• Primary Technical and Efficacy Endpoint - Measure 1: Technical Success at Completion of the Procedure [Срок оценки: At completion of the index procedure]
• Primary Technical and Efficacy Endpoint - Measure 2: Procedural Technical Success and TR ≤Moderate at Hospital Discharge [Срок оценки: At hospital discharge following the index procedure]

Вторичные конечные точки (4)

• Secondary Endpoint - NYHA Functional Class at 30, 90, 180, and 365-Days Post-Procedure [Срок оценки: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)]
• Secondary Endpoint - KCCQ at 30, 90, 180, and 365-Days Post-Procedure [Срок оценки: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)]
• Secondary Endpoint - 6MWT at 30, 90, 180, and 365-Days Post-Procedure [Срок оценки: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)]
• Secondary Endpoint - Tricuspid Regurgitation at 30, 90, 180, and 365-Days Post-Procedure [Срок оценки: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)]

Критерии участия

Критерии включения

• 18-90 years old at the time of consent
• Symptomatic functional tricuspid regurgitation (without co-existing degenerative disease) despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the study consent
• Severe, massive or torrential functional tricuspid regurgitation, as determined by qualifying transesophageal echocardiogram (TEE) and/or transthoracic echocardiogram (TTE) using the 5-grade classification
• TEE imaging confirms adequate visualization of valve for TR quantification and procedural guidance
• The Local Heart Team determines the candidate is suitable for transcatheter tricuspid valve repair
• Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits

Критерии исключения

• Estimated life expectancy of less than 12 months
• Systolic pulmonary artery pressure (sPAP) >70 mmHg as assessed by TTE or right heart catheterization
• Acutely decompensated, defined as hypotension with SBP <90 mmHg, use of hemodynamic support devices or inotropes or uncontrolled arterial hypertension with SBP >180 mmHg within 30 days of the study procedure
• Severe COPD dependent on home oxygen or chronic home oxygen use
• Echocardiographic evidence of severe right ventricular dysfunction
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment (prior transcatheter or surgical treatment allowable)
• Any condition that would interfere with the procedure, such as prior tricuspid valve repair, tricuspid valve leaflet anatomy which may preclude device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle)
• Tricuspid valve stenosis defined as a tricuspid valve orifice of ≤1.0 cm2 and/or mean gradient of ≥5 mmHg
• New or untreated right heart chamber and/or superior vena cava intracardiac mass, thrombus, or vegetation
• Degenerative tricuspid or rheumatic tricuspid valve disease
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the study procedure
• Implant or revision of any rhythm management device (CRT or CRT-D, ICD, or leadless pacemaker) within 90 days prior to the study procedure
• Known need for emergent, urgent, or planned surgery or intervention within 30 days following the study procedure, or planned or scheduled cardiac surgery within 12 months following the study procedure
• Stroke or other major cerebrovascular event within 90 days prior to the study procedure
• Untreated clinically significant coronary artery disease requiring revascularization, recent (within 30 days of the study procedure) acute coronary syndrome or myocardial infarction
• Active or recent GI bleed within 30 days prior to the study procedure, or patients contraindicated for oral anticoagulation therapy
• Bleeding disorders including thrombocytopenia (platelet count <70,000 mm3) or thrombocytosis (platelet count >700,000 mm3)
• Transfusion-dependent chronic anemia with Hb <9/dL
• Current or planned pregnancy within 12 months of the study procedure for women of childbearing potential
• Active or recent endocarditis within 90 days of the study procedure, or sepsis/other systemic infection requiring oral or intravenous antibiotics within 30 days of the study procedure
• Prior tricuspid repair or tricuspid replacement or prosthetic implant that would interfere with successful deployment or functioning of the Tangent Implant
• Participation in another pre-market investigational device study or investigational drug study (for a cardiac-related drug)
• Presence of other anatomic or co-morbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's availability to participate in the clinical investigation or to comply with follow-up requirements
• Any patient considered to be vulnerable
• Left ventricular ejection fraction (LVEF) <30%
• Deep vein thrombosis or pulmonary embolism within 6 months of the study procedure
• Child-Pugh C cirrhosis

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

Paraguay · 1 центр

• Sanatorio Italiano — Asunción

Идентификаторы

NCT: NCT07140562 · CD-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗