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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lei Liu
- Numer telefonu: 8615215607933
- E-mail: liulei@fuwai.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Experimental: PFA Ablation Group
Participants with paroxysmal atrial fibrillation receive pulsed field ablation (PFA) guided by CARTO SOUND™ FAM for pulmonary vein isolation.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Acute Procedural Success Composite Endpoint
Ramy czasowe: 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.
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Immediately after the ablation procedure
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of 30-Day Serious Adverse Events (SAEs)
Ramy czasowe: 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
Ramy czasowe: Intraoperative (Day 0)
|
Total procedure duration, measured in minutes from femoral vein puncture to sheath removal.
|
Intraoperative (Day 0)
|
|
Mapping Time
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
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Catheter Contact Quality Assessed by ICE
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-3023
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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