A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation (CSPFA)
An Exploratory Study on Pulmonary Vein Pulsed Field Ablation Guided by CARTO SOUND™ FAM
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Background and Rationale Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. While pulsed field ablation (PFA) offers a non-thermal, tissue-selective energy source that minimizes collateral damage to adjacent structures (such as the esophagus and phrenic nerve), its efficacy heavily relies on the precise anatomical positioning of the ablation catheter within the complex left atrial (LA) anatomy. Current LA reconstruction methods have limitations: conventional fast anatomical mapping (FAM) requires extensive catheter manipulation, and CT/MRI integration exposes patients to radiation, contrast agents, and additional costs.
The CARTO SOUND™ FAM system addresses these challenges by integrating intracardiac echocardiography (ICE) with a three-dimensional mapping platform. Utilizing an artificial intelligence algorithm, it generates a precise 3D LA model directly from 2D ICE frames acquired from the right atrium and right ventricular outflow tract. This approach aims to reduce LA mapping time while improving the anatomical definition of critical structures, such as the ridge between the left atrial appendage and the pulmonary veins.
Procedural Workflow and Intervention Details This prospective, multicenter study is designed to evaluate the clinical feasibility and acute procedural workflow of combining the CARTO SOUND™ FAM system with PFA. During the procedure, following a transseptal puncture, the CARTO SOUND™ FAM system utilizing an ICE catheter will be deployed to efficiently reconstruct a detailed 3D model of the left atrium and pulmonary veins without crossing the septum with the mapping catheter initially.
Guided by this real-time ultrasound-derived 3D anatomical model, operators will navigate the Varipulse™ PFA catheter to deliver pulsed-field energy for the electrical isolation of target pulmonary veins. The VIZIGO™ steerable sheath may be adjunctive utilized to optimize catheter stability and positioning. Post-ablation, patients will undergo standard clinical management and will be followed for 30 days with continuous monitoring (including 12-lead ECG, 24-hour Holter, and echocardiography) to assess both acute electrophysiological success and short-term procedural safety.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Lei Liu
- Номер телефона: 8615215607933
- Электронная почта: liulei@fuwai.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Diagnosis of paroxysmal atrial fibrillation with an indication for catheter ablation.
- Willing and able to provide written informed consent.
- Age between 18 and 80 years (inclusive).
- Able and willing to comply with all pre-procedure, post-procedure, and follow-up visits and assessments.
Exclusion Criteria:
- Valvular atrial fibrillation, untreated or uncontrolled thyroid disease, acute coronary syndrome, or atrial fibrillation secondary to cardiomyopathy.
- Any contraindication to catheter ablation (e.g., left atrial thrombus, coagulopathy preventing anticoagulation, severe hepatic/renal dysfunction, psychiatric illness).
- Pregnancy or breastfeeding.
- Malignancy, cachexia, severe ascites, body mass index (BMI) > 40 kg/m², or severe sleep apnea syndrome.
- Participation in another clinical study.
- Any other condition that the investigator considers inappropriate for study participation.
- Contraindication to any study device as specified in the respective instructions for use (IFU).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental: PFA Ablation Group
Participants with paroxysmal atrial fibrillation receive pulsed field ablation (PFA) guided by CARTO SOUND™ FAM for pulmonary vein isolation.
|
Pulsed field ablation is delivered via the Varipulse™ catheter to isolate pulmonary veins, guided by the CARTO SOUND™ FAM system which uses intracardiac echocardiography to reconstruct a 3D model of the left atrium.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Acute Procedural Success Composite Endpoint
Временное ограничение: Immediately after the ablation procedure
|
The composite endpoint defined as meeting all of the following criteria: (1) successful construction of left atrial model using the study catheter; (2) electrical isolation of all target pulmonary veins (entry block confirmed, exit block as needed); (3) completion of entire ablation using only study devices, without cross-over to other ablation tools.
|
Immediately after the ablation procedure
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of 30-Day Serious Adverse Events (SAEs)
Временное ограничение: Up to 30 days post-procedure
|
Number of participants experiencing SAEs related to the CARTO SOUND™ FAM or PFA procedure.
|
Up to 30 days post-procedure
|
|
Total Procedure Time
Временное ограничение: Intraoperative (Day 0)
|
Total procedure duration, measured in minutes from femoral vein puncture to sheath removal.
|
Intraoperative (Day 0)
|
|
Mapping Time
Временное ограничение: During the procedure (Day 0)
|
The duration required to complete the electroanatomical mapping using CARTO SOUND™ FAM, measured in minutes.
|
During the procedure (Day 0)
|
|
Total Ablation Time
Временное ограничение: During the procedure (Day 0)
|
The cumulative duration of pulsed field ablation (PFA) energy delivery, measured in minutes.
|
During the procedure (Day 0)
|
|
Fluoroscopy Time
Временное ограничение: During the procedure (Day 0)
|
The duration of fluoroscopy exposure, including both the total fluoroscopy time and the specific fluoroscopy time during the mapping phase, measured in minutes.
|
During the procedure (Day 0)
|
|
Catheter Contact Quality Assessed by ICE
Временное ограничение: During the procedure (Day 0)
|
The quality of contact between the ablation catheter and the cardiac tissue, as assessed by Intracardiac Echocardiography (ICE).
|
During the procedure (Day 0)
|
|
Percentage of Positive Tissue Proximity Indicator (TPI) Sites
Временное ограничение: During the procedure (Day 0)
|
The percentage of ablation sites showing positive Tissue Proximity Indicator (TPI) signals out of the total number of ablation sites.
|
During the procedure (Day 0)
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025-3023
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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