The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US

Обзор

Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy, who have been determined by the site's local heart team to be at intermediate or greater estimated risk for mortality and morbidity with tricuspid valve surgery.

Подробное описание

A prospective, multi-center, randomized, controlled, pivotal study of the MIA Percutaneous Tricuspid Annuloplasty System (MIA-T) in symptomatic subjects with severe (≥3) TR despite optimal medical therapy.

The study will randomize eligible subjects in two (2) cohorts at up to 40 sites.

Вмешательства

• Устройство MIA_T Device
  MIA-T Device

Первичные конечные точки

• Primary Efficacy Endpoint [Срок оценки: 12 months]
• Primary Safety Endpoint [Срок оценки: 30 days]

Вторичные конечные точки (12)

• Freedom from all-cause mortality at all study timepoints [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Freedom from heart failure hospitalizations at all study timepoints [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Clinical Success Rate [Срок оценки: 1Month]
• Intraprocedural Success Rate [Срок оценки: 1Month]
• Freedom from Major Adverse Events (MAE) at all study time points. [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Prevalence of Device or Procedure-Related Adverse Events (AE) [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Core Lab assessment of change in other pertinent echo [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Change in NT-proBNP [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Change in gamma-GTP [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Change in eGFR [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Change in MELD score (liver function) [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
• Change in SF-36 QoL scores [Срок оценки: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]

Критерии участия

Критерии включения

• Subject has severe functional TR (≥ 3). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
• In the judgment of the site's local heart team patient is at intermediate or greater risk for morbidity \& mortality with tricuspid valve surgery, and has been adequately treated per applicable standards with optimized medical therapy for the treatment of TR (e.g. diuretics) and stable for at least 30 days prior to enrollment.
• New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV

Критерии исключения

• Systolic pulmonary artery pressure (sPAP) > 70 mmHg or > 5 wood units (WU) despite vasodilator therapy
• Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
• Previous tricuspid valve repair or replacement (transcatheter or surgical approach)
• Subjects with concomitant left-sided valve disease will have the option of receiving a left-sided intervention (e.g. TMVR or TAVR) and waiting 60 days prior to being reassessed for the study
• Myocardial infarction (MI), known unstable angina, symptomatic coronary artery disease (CAD) where revascularization is possible within 60 days prior to enrollment
• Anatomy that precludes safe placement of anchors around the annulus
• Hemodynamic instability defined as systolic pressure < 90 mmHg requiring pressor support within the last 30 days

Echo Criteria -

• Subject has severe functional TR (determined by the ICL). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
• No presence of Cardiac Implantable Electronic Devices (CIED) leads causing the TR
• No significant annular calcification
• Left Ventricular Ejection Fraction (LVEF) ≥ 20%

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06700239 · MID-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗