FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis

Официальное название

First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis

Обзор

The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis. This is a prospective, open label, multicentre, single arm, first in human clinical study. Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation

Вмешательства

• Устройство GEMINUS Transcatheter Aortic Valve Implantation system
  Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system

Первичные конечные точки

• Technical success (at exit from procedure room) [Срок оценки: immediately after procedure]

Вторичные конечные точки (12)

• Device success composite endpoint [Срок оценки: 30 days]
• Early safety composite endpoint (VARC 3) [Срок оценки: 30 days]
• Early safety composite endpoint (Modified VARC) [Срок оценки: 30 days]
• Clinical efficacy composite endpoint [Срок оценки: 1, 2, 3, 4, 5 years]
• All-cause mortality [Срок оценки: 30 days, 6 months, 1, 2, 3, 4, 5 years]
• Disabling stroke [Срок оценки: 6 months, 2, 3, 4, 5 years]
• Any stroke [Срок оценки: 30 days, 6 months, 1, 2, 3, 4, 5 years]
• Peri-procedural MI (per ARC-2) [Срок оценки: within 2 days after procedure]
• Repeat hospitalization for procedure or valve related cause [Срок оценки: 30 days, 6 months, 1, 2, 3, 4, 5 years]
• Repeat aortic valve intervention [Срок оценки: 30 days, 6 months, 1, 2, 3, 4, 5 years]
• AKI (Stage 3 or 4) [Срок оценки: 30 days]
• Bleeding ≥ VARC-3 type 2 [Срок оценки: 30 days, 6 months, 1, 2, 3, 4, 5 years]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Patient understands the implications of participating in the study and provides informed consent
• Patient is willing to comply with specified follow-up evaluation
• Severe aortic stenosis as per ACC/AHA 2020 guidelines (e.g. AVA ≤ 1.0 cm2 (or AVA index ≤ 0.6cm2/m2)\* AND PV ≥ 4 m/sec or mean gradient ≥ 40 mmHg)\*\* as determined by TTE/CT-TAVI

\*May be larger with mixed AS/AR

\*\*For low flow low gradient AS or paradoxical low flow severe AS must meet ACC/AHA guidelines (table 13 stages of AS in the guideline)

• Cardiac Symptoms: ≥ NYHA Class II
• Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old.
• Aortic annulus diameter ≥22 mm and < 29 mm, assessed by CT TAVI
• Anatomically suitable for implantation of the GEMINUS device
• Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter > 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system.
• Patients assessed by the heart team to be at high risk for access site related bleeding/vascular complications due to the caliber/ calcification/ atherosclerosis of the iliofemoral vessels.

Критерии исключения

• Patient not suitable for surgical bailout
• Congenital uni/bi/quadricuspid valve, or noncalcified aortic valve.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation ≥3+).
• Active or recent (within 6 months) endocarditis.
• Active systemic infections.
• Recent MI (≤ 1 month).
• Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure.
• Prosthetic heart valve in any position.
• Severe (> 3+) mitral, tricuspid or pulmonic regurgitation.
• Blood dyscrasias as defined: leukopenia (WBC<3000/mm3), acute anemia (Hb <8mg%), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hemodynamic instability requiring inotropic support or mechanical support devices.
• Hypertrophic cardiomyopathy with or without obstruction (HCM).
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active peptic ulcer or upper GI bleeding within the prior 3 months.
• Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated).
• Recent (<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Renal insufficiency (eGFR<30 mL/min) and/or end stage renal disease requiring chronic dialysis.
• Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter > 5cm), marked tortuosity, or severe aortic arch atheroma.
• Life expectancy < 12 months due to non-cardiac co-morbid conditions.
• Currently participating in an investigational drug or another device study that has not reached its primary endpoint

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

Израиль · 2 центра

• Rabin Medical Center — Petah Tikva
• Tel Aviv Sourasly Medical Center — Tel Aviv

Идентификаторы

NCT: NCT05909748 · GEMINUS-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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