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A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation (CSPFA)

14. Mai 2026 aktualisiert von: Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases

An Exploratory Study on Pulmonary Vein Pulsed Field Ablation Guided by CARTO SOUND™ FAM

This study is being done to see if a new method for treating a heart rhythm problem called paroxysmal atrial fibrillation (AFib) is safe and works well. AFib causes the upper chambers of the heart (the atria) to beat irregularly, which can lead to symptoms like palpitations, shortness of breath, and tiredness. The usual treatment for AFib when medicines do not help is a procedure called catheter ablation. This procedure uses heat or cold to create small scars in the heart to block abnormal electrical signals. This study uses a newer energy source called pulsed field ablation (PFA), which may be safer for the surrounding tissues (like the esophagus and nerves) because it mainly affects heart cells. Another special part of this study is how doctors build a 3D picture of the left atrium - the part of the heart where AFib starts. Instead of the standard method, the investigators will use a technology called CARTO SOUND™ FAM. This combines heart ultrasound (ICE) with a mapping system to quickly create an accurate 3D model of the left atrium without needing a CT scan or extra injections of dye. The main questions are: Can the doctor successfully isolate all four pulmonary veins (the areas where AFib often starts) using only the study devices (CARTO SOUND™ FAM and PFA)? What are the side effects and safety of this new combination within 30 days after the procedure? About 70 adults aged 18 to 80 with paroxysmal AFib will take part. Participants will have one ablation procedure and will be followed for 1 month after the procedure. The study will measure how long the procedure takes, how much X-ray is used, how well the catheter touches the heart tissue, and any serious medical events. This is an early (feasibility) study to gather information for future, larger studies. It is sponsored by Fuwai Hospital, Chinese Academy of Medical Sciences, and will be done in three hospitals in China.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental: PFA Ablation Group
Participants with paroxysmal atrial fibrillation receive pulsed field ablation (PFA) guided by CARTO SOUND™ FAM for pulmonary vein isolation.
Gerät: CARTO SOUND™ FAM System with Varipulse™ PFA Catheter
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acute Procedural Success Composite Endpoint
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of 30-Day Serious Adverse Events (SAEs)
Zeitfenster: 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
Zeitfenster: Intraoperative (Day 0)
Total procedure duration, measured in minutes from femoral vein puncture to sheath removal.
Intraoperative (Day 0)
Mapping Time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

China National Center for Cardiovascular Diseases

Mitarbeiter

The Affiliated Hospital of Qingdao University
Central China Fuwai Hospital of Zhengzhou University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

30. August 2027

Studienanmeldedaten

Zuerst eingereicht

23. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. April 2026

Zuerst gepostet (Tatsächlich)

7. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025-3023

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

The study did not obtain informed consent from participants for sharing individual participant data (IPD) with external researchers. Additionally, the data are owned by Fuwai Hospital and are subject to institutional confidentiality policies.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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