Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)

Официальное название

GUARDIAN Australian Feasibility Study: Safety and Feasibility

Обзор

The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device. The study will be conducted to evaluate the device design concept with respect to clinical safety and device functionality.

Подробное описание

This is a prospective, single-arm, multi-center, open study to assess the clinical performance and safety of the Point-Guard CEPD during a TAVR procedure.

Вмешательства

• Устройство cerebral embolic protection
  Use of Transverse Medical Inc. Point-Guard CEP device.

Первичные конечные точки

• Primary Endpoint [Срок оценки: From beginning of TAVI procedure to end.]
• Primary Safety Endpoints [Срок оценки: Beginning of TAVI procedure to 30 days post-procedure.]

Критерии участия

Критерии включения

• The patient is ≥18 years of age;
• The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
• The patient is willing to comply with protocol-specified follow-up evaluations;
• The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.

Критерии исключения

• TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• Anatomy that precludes safe delivery and retrieval of the investigational device.
• Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
• Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
• Patients with uncontrolled bleeding disorders.
• Patients who are pregnant, as confirmed by a positive pregnancy test.

General Exclusion Criteria

• TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• Anatomy that precludes safe delivery and retrieval of the investigational device.
• Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
• Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
• Patients with uncontrolled bleeding disorders.

5\. Patients who are pregnant, as confirmed by a positive pregnancy test.

Magnetic resonance imaging exclusion criteria:

• Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
• Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
• High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., subjects with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
• Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
• Claustrophobia precluding MRI scanning.

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

• Victorian Heart Hospital — Clayton

Идентификаторы

NCT: NCT06962371 · CA-0007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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