The MAGiC™ Cardiac Ablation European Study

Официальное название

The MAGiC™ Cardiac Ablation Feasibility Study / Pomt Market Clinical Follow-Up

Обзор

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. The purpose of MAGiC-FEST PMCF Study is to collect safety and performance data with MAGiC to meet ongoing regulatory obligations.

Подробное описание

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. Now that MAGiC obtained European approval, the study has been amended and expanded to collect Post-Market Clinical Follow-up data.

Вмешательства

• Устройство MAGiC™
  Robotic magnetic radiofrequency (RF) ablation catheter

Первичные конечные точки

• Acute Performance [Срок оценки: hospital discharge - up to 7 days post procedure]
• Acute Safety [Срок оценки: hospital discharge - up to 7 days post procedure]

Вторичные конечные точки (3)

• Chronic Success [Срок оценки: 3 months, 6 months, 12 months]
• Safety Events [Срок оценки: 3 months, 6 months, 12 months]
• Onset of Procedure-related New Arrhythmia [Срок оценки: 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• Adult (aged 18 or older at time of consent);
• Eligible for ablation procedures of an atrial or ventricular arrhythmia per European Heart Rhythm Association (EHRA) guidelines, lctrocardiographically documented within 12 months \[rior to enrollment;
• Able to be safely exposed to magnetic fields;
• Willing and capable to attend scheduled follow up visits at the study site for the study duration (up to 12 months)
• Willing and able to provide informed consent.

Критерии исключения

• Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely removed for the procedure)
• Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time
• Weight exceeding 200 kg (the weight limit of the table)
• Women of childbearing age who are pregnant or who plan to become pregnant within the course of their participation in the study. Must have a negative pregnancy test.
• Presence of intracardiac thrombus within 12 weeks prior to enrollment
• Where MAGiC would need to cross a prosthetic valve
• Use of MAGiC in the coronary arteries
• A history of sensitivity to foreign objects or extreme allergies
• Acute illness or active systemic infection
• Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection
• Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Acute myocardial infarct (within the previous 6 weeks)
• Recent cardiac surgery (within the previous 8 weeks)
• Unstable angina at the time of enrollment
• History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days
• Previous cardiac ablation within the previous 30 days
• EP ablation within the previous 6 weeks.
• Life expectancy <12 months per the physician opinion.
• Currently or in the 30 days prior to consent, participation in an interventional clinical trial
• Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study (limitation on survival).
• Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation.

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

Дания · 1 центр

• Rigshospitalet, University of Copenhagen — Copenhagen

Литва · 1 центр

• Vilniaus universiteto ligoninė Santaros klinikos — Vilnius

Нидерланды · 1 центр

• Erasmus Medical Center — Rotterdam

Польша · 1 центр

• National Institute of Cardiology — Warsaw

Идентификаторы

NCT: NCT06019845 · MFEAS-001 · CIV-23-10-044301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗