Capstan Medical TMVR Study: FIH

Официальное название

Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System

Обзор

This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.

Вмешательства

• Устройство Capstan System transcatheter mitral valve replacement
  This is a first human use trial exploring a novel transcatheter mitral valve replacement implant and electro-mechanical delivery system. The device offers a minimally invasive repair for patients who have at symptomatic regurgitation who are otherwise ineligable for surgical intervention, or who have no other prospects for treatment and in whom medical therapy has already been optimised.

Первичные конечные точки

• Incidence of procedural success [Срок оценки: Procedure through 30 days]

Вторичные конечные точки (2)

• Technical Success [Срок оценки: 30-Days]
• Freedom from MAE [Срок оценки: 30-days, 90-days, 6-months, 1-year, then annually to 5-years]

Критерии участия

Критерии включения

• Age ≥ 18 years at the time of consent.
• Moderate-severe (3+) or severe (4+) mitral regurgitation
• NYHA II or greater symptoms despite optimal medical treatment.
• The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).
• Ability and willingness to provide written informed consent prior to any study related procedure(s).

Критерии исключения

• LVEF less than 20%
• Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System
• Severe aortic valve stenosis or regurgitation
• Severe mitral stenosis
• Severe right ventricular dysfunction or severe tricuspid valve disease
• Evidence of intracardiac thrombus, vegetation, or mass
• Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve
• Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure
• Myocardial infarction within 30 days prior to procedure
• Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure
• Active endocarditis, other ongoing infection requiring antibiotic therapy
• Stroke or transient ischemic attack (TIA) within 30 days of procedure
• Active peptic ulcer or active gastrointestinal bleeding
• Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg
• End-stage renal failure on dialysis
• Life expectancy less than 1 year
• Subject is on the waiting list for a heart transplant or has had a prior heart transplant
• Pregnant (Participants of childbearing age are required to have a negative pregnancy test).
• Known allergy to antiplatelet therapy, heparin, or to device materials
• Inability to tolerate anticoagulation or antiplatelet therapies
• Absence of appropriate venous access
• Unable to have transesophageal echocardiography
• Unwillingness to complete the required follow-up visits

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

Оценка устройства

Центры проведения

Австралия · 1 центр

• Monash Health, Victorian Heart Hospital — Melbourne

Чили · 1 центр

• Pontificia Universidad Católica de Chile — Santiago

Новая Зеландия · 1 центр

• Auckland City Hospital — Auckland

Идентификаторы

NCT: NCT06600191 · CL_03945

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗