Идёт набор NCT07324031

Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study

Без фазы С лечением Ventricular Arrythmia Ventricular Fibrillation Ventricular Tachycardia

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: Atala™ lead and EV-ICD Pulse Generator.
Кому может быть актуально: Состояния в реестре: Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia. Базовые параметры: от 18 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: США, Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of this pivotal study is to generate evidence of safety and effectiveness to apply for regulatory approvals for commercialization of the Parasternal EV-ICD System. The objective of the study is to demonstrate safety and effectiveness of the Parasternal EV-ICD System through 6-months.

Подробное описание

The primary safety endpoint is Freedom from Major Adverse Device Effects (MADEs) through 6 months. The primary effectiveness endpoint is Defibrillation Performance: Successful induced ventricular arrhythmia (IVA) test in the final system configuration.

Up to 40 Investigational Sites Worldwide will participate with up to 280 subjects enrolled in the study. At least 50% of subjects will be enrolled at sites in the United States.

Subjects meeting indications for ICD therapy who do not require permanent bradycardia pacing will be eligible for participation. Eligible Subjects will receive an Atala™ lead connected to an EV-ICD Pulse Generator positioned in a left pectoral or left lateral location. The Parasternal EV-ICD System will be tested to verify appropriate sensing and defibrillation.

Starting at 6 months, Subjects will be followed every 6 months until the study is closed. The study is expected to be ongoing for a minimum of 2.5 years from the date of first enrollment. Endpoints will be analyzed and summarized in a final study report after all active Subjects have completed the 6-month visit.

Вмешательства

Устройство Atala™ lead and EV-ICD Pulse Generator
Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.

Первичные конечные точки

Freedom from MADEs [Срок оценки: Through 6 months post-implant]
Successful IVA Test [Срок оценки: At the time of procedure and up to 60 days post-implant]

Критерии участия

Критерии включения

At least 18 years old
Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines

Критерии исключения

Patients who cannot read or write
Expected survival < 1 year
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
Participation in any concurrent clinical study without prior approval from the Sponsor
Inability or unwillingness to provide informed consent to participate in the study
Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
Circumstances that may prevent data collection or completion of specified follow-up visits
Allergies to any device materials listed in the Instructions for Use (IFU)
Contraindication for temporary suspension of oral/systemic anticoagulation
Known history of lung disease with FEV1 < 1.0 Liter

Device Related:

Implanted with or planned implantation of any device which delivers current in the body that may interfere with therapy delivery, including, but not limited to a pacemaker, LVAD or neurostimulator
Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
Any known need for MRI prior to approval of MRI conditional labeling

Anatomy Related:

Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure
Known obstructed or restricted pathway into the mediastinum for the Atala™ lead
Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type
Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure
Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
Surgically corrected congenital heart disease (not including catheter-based procedures)

Cardiac Related:

Indication for permanent bradycardia pacing or cardiac resynchronization therapy
Decompensated heart failure
Currently on inotropic therapy
Known history of pericardial disease, pericarditis or mediastinitis
Risk factors associated with defibrillation testing:

Severe aortic stenosis
Current Intracardiac LA or LV thrombus
Severe proximal three-vessel or left main coronary artery disease without revascularization
Hemodynamic instability
Unstable angina
Recent stroke or transient ischemic attack (within the last 3 months)
Known inadequate external defibrillation
LVEF < 20% (most recent assessment; must be within 180 days of consent)
LVEDD >70 mm (most recent assessment; must be within 180 days of consent)

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

Здоровые добровольцы: Нет