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Идёт набор NCT06507579

Hydra Registry - UK

— Наблюдательное Aortic Valve Stenosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hydra transcatheter aortic valve (THV) series.
Кому может быть актуально
Состояния в реестре: Aortic Valve Stenosis. Базовые параметры: 18 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Обзор

The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.

Подробное описание

This is a prospective, observational, multi-centre study. The aim of this study is to collect clinical, procedural, and follow-up data in order to evaluate the efficacy and safety of the Hydra THV series (Vascular Innovations Co. Ltd., Nonthaburi, Thailand).

Additionally, the study will conduct the following evaluation:

1. The remote ambulatory cardiac monitoring (rACM) using the Checkpoint Cardio System, consisting of 72 hours of continuous electrocardiogram (ECG) monitoring, will be evaluated post hospital discharge where it is clinically appropriate. 2. Coronary access will be evaluated immediately post-TAVI by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. This will be done in a sub-set of patients who are either known to have coronary artery disease, did not have coronary angiogram prior to TAVI or where it is felt to be clinically appropriate for other reasons post implant.

Following discharge, clinical follow-ups are scheduled at 45 days (±14 days), and 1-year (±30 days).

Вмешательства

  • Устройство Hydra transcatheter aortic valve (THV) series
    The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

Первичные конечные точки

  • Primary safety endpoint [Срок оценки: 45 days]
  • Primary performance endpoint [Срок оценки: 45 days]
Вторичные конечные точки (12)
  • Technical success [Срок оценки: Immediately after the procedure]
  • Cardiovascular mortality [Срок оценки: 45 days, and 1-year]
  • All-cause mortality [Срок оценки: 45 days, and 1-year]
  • All stroke [Срок оценки: 45 days, and 1-year]
  • Disabling stroke [Срок оценки: 45 days, and 1-year]
  • Myocardial infarction [Срок оценки: 45 days, and 1-year]
  • Major vascular complication [Срок оценки: 45 days]
  • Acute kidney injury [Срок оценки: 45 days]
  • New permanent pacemaker implantation due to procedure related conduction abnormalities [Срок оценки: 45 days, and 1-year]
  • New-onset atrial fibrillation [Срок оценки: 45 days, and 1-year]
  • Coronary artery obstruction requiring intervention [Срок оценки: 45 days, and 1-year]
  • Re-hospitalization for procedure- or valve-related causes [Срок оценки: 45 days, and 1-year]

Критерии участия

Критерии включения

  • Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
  • Full understanding and willing to provide informed consent to study enrolment
  • Age ≥ 18 years

Критерии исключения

  • Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
  • Refusal to provide informed consent to study enrolment
  • Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
  • Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Великобритания · 4 центра
  • Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield
  • Royal Victoria Hospital — Belfast
  • Royal Papworth — Cambridge
  • Castle Hill Hull — Cottingham

Идентификаторы

NCT: NCT06507579 · HYD/SHEFFIELD-001/2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗