Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
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: Free Margin Cusp Sizer.
- Кому может быть актуально
- Состояния в реестре: Aortic Valve Regurgitation, Aortic Root Aneurysm. Базовые параметры: 18 лет — 80 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery
Обзор
The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length at different stages of the procedure. The patient will be followed for one year clinically (at 1, 2, 6 and 12 months) and by echocardiography (at 6 and 12 months) to assess aortic valve function.
Подробное описание
Goal of the study :
The objective of this study is to study the safety and reliability of a new surgical instrument, the "Free Margin Cusp Sizer" (patented device). The measuring instrument will be used during aortic valve repair procedures to measure the length of the free edge of the aortic cusps.
State of the art :
Currently, aortic valve repair is done by visual estimation and requires a great level of experience from the surgeon. We proposed to develop an objective cusp repair technique based on the measurement of the free edge by a dedicated sizer. The measuring instrument will give the objective difference in millimeters between the normal cusp and the one with prolapse. This will then be quantitatively plicatured to correct its excess length. This new technique will allow less experienced surgeons or those in the process of learning objective guidance of valve repair. The objective measure of the free edge length may also orient the sizing of the Dacron graft used for valve sparing root replacement.
Study evaluation criteria:
* Hospital mortality (mortality at 30 days), MACCE at one year: mortality, cerebrovascular accident or transient ischemic attack, major hemorrhage, cardiac reoperation * Echocardiographic results at discharge from hospital and at 6 months or one year
Material and methods:
* Single-center, prospective, non-randomized study * Patient source: Patients operated for aortic valve repair or aortic valve sparing surgery at Cliniques Universitaires Saint-Luc (CUSL), Brussels * Number of patients to be included: 120, study duration: 6,5 years, inclusion period: 5,5 years, follow-up:
1 year * Inclusion criteria: patient with a tricuspid aortic valve operated electively for aortic valve insufficiency or dilation of the ascending aorta * Exclusion criteria: acute aortic dissection, diffuse aortic valve calcification, endocarditis, bicuspide, unicuspid or quadricuspid aortic valve, patient under 18 and over 80
Data acquisition and patient follow-up:
The examinations carried out within the framework of this study are the same as those carried out routinely during the preoperative cardiac assessment and clinical follow-up after aortic valve repair:
* Preoperative cardiovascular examination including TTE (transthoracic ultrasound) / TEE (transesophageal ultrasound) * Intraoperative TEE pre and post aortic valve repair * TTE at discharge * TTE between 6 months and one year postoperatively * 1 month post-operative consultation (outpatient surgery) * Consultation 1 to 2 months postoperative (referring cardiologist) * Consultation 6-12 months postoperative (referring cardiologist) (if necessary, phone contact with the patient at 12-14 months)
Вмешательства
- Устройство Free Margin Cusp Sizer
The free margin cusp sizer will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length.
Первичные конечные точки
- Intraoperative aortic valve (AV) damage [Срок оценки: 30 days]
- Hospital mortality [Срок оценки: 30 days]
- Major adverse cardiac and cerebrovascular events (MACCE) [Срок оценки: one year]
- Aortic valve function [Срок оценки: One year]
Вторичные конечные точки (1)
- Pre-repair free margin length [Срок оценки: Intraoperative]
Критерии участия
Критерии включения
- Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.
Критерии исключения
- Acute aortic dissection;
- Diffuse aortic valve calcification;
- AV endocarditis;
- Bicuspid, unicuspid or quadricuspid aortic valves;
- Patients under the age of 18 years;
- Patients above the age of 80 years.
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
Бельгия · 1 центр
- Cliniques Universitaires Saint-Luc — Brussels
Публикации
- De Kerchove L, Momeni M, Aphram G, Watremez C, Bollen X, Jashari R, Boodhwani M, Astarci P, Noirhomme P, El Khoury G. Free margin length and coaptation surface area in normal tricuspid aortic valve: an anatomical study. Eur J Cardiothorac Surg. 2018 May 1;53(5):1040-1048. doi: 10.1093/ejcts/ezx456. PMID 29253123
- Tamer S, Mastrobuoni S, van Dyck M, Navarra E, Bollen X, Poncelet A, Noirhomme P, Astarci P, El Khoury G, de Kerchove L. Free margin length and geometric height in aortic root dilatation and leaflet prolapse: implications for aortic valve repair surgery. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):124-132. doi: 10.1093/ejcts/ezz132. PMID 31089691
Идентификаторы
NCT: NCT04797572 · CALIBRATE TRIAL01 · 2020-14DEC/619