NCT07294742Fut, nem toboroz
Using a Novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation
First-in-Human Experience Using a Novel Balloon-shaped Large-Focal Pulsed Field Ablation Catheter in Persistent Atrial Fibrillation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 19.
Rövid összefoglaló (regiszter, angolul)
This clinical trial aims to evaluate the safety and effectiveness of pulmonary vein isolation (PVI) and linear ablation using a large-focal pulsed field ablation (PFA) catheter in patients with persistent atrial fibrillation (perAF). The study will address two primary questions: 1. Is the procedure safe, as determined by the absence of serious device- or procedure-related adverse events within 7 days post-ablation? 2. Is the catheter effective in creating durable lesions, as assessed by invasive electrophysiological remapping? Study Design and Intervention Eligible patients with perAF underwent PVI and linear ablation under general anesthesia using the PFApple large-focal PFA catheter. The catheter delivers a biphasic, bipolar pulsed electric field (1000V, 0.04 ms pulse duration) to create spherical ablation lesions. Participant Follow-up Protocol Enrolled participants will complete the following assessments: 1. Index Procedure: PVI and linear ablation with the PFApple PFA catheter. 2. Durability Assessment: Repeat invasive electrophysiological remapping at 3 months post-ablation to evaluate lesion durability. 3. Clinical Follow-up: Scheduled visits at 7 days, 30 days, 3 months, 6 months, and 12 months post-procedure. Atrial tachyarrhythmia recurrence is assessed via 12-lead electrocardiography at each visit and 24-hour or 7-day Holter monitoring at the 6- and 12-month time points.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 34 (tényleges)
- Első benyújtás
- 2025. dec. 8.
- Kezdés
- 2024. nov. 6.
- Elsődleges befejezés
- 2025. máj. 29.
- Fő szponzor
- The Third People's Hospital of Chengdu
- Betegségek
- Pitvarfibrilláció
- NCT-szám
- NCT07294742
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 34
- 2024. nov. 6. és az elsődleges befejezés (2025. máj. 29.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Pulmonary vein (PV) stenosis (>70%) or prior PV stent implantation
- History of any of the following within 3 months prior to the procedure:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Cardiac surgery (including coronary artery bypass grafting)
- Hospitalization for heart failure
- Pericarditis
- History of any of the following within 3 months prior to the procedure:
- Cerebral infarction or transient ischemic attack (TIA)
- Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography [TEE])
Más betegség
- AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
- History of left atrial ablation or cardiac surgery (including left atrial appendage closure)
- Implantation of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function)
- Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities
- Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities
- History of malignant tumor or expected life expectancy < 12 months
- Mental disorders or history of mental illness with inability to cooperate independently
- Acute or severe systemic infection, or significant abnormalities in liver/renal function
Laborértékek
- Any of the following cardiac surgeries, implants, or conditions:
- Prosthetic heart valve
- NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) < 40%
- Atrial septal defect or ventricular septal defect closure
- Atrial myxoma, left atrial appendage device implantation or occlusion
Egyéb
- Paroxysmal atrial fibrillation (AF)
- Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
- Patients with sustained ventricular tachycardia or ventricular fibrillation
- Left atrial anteroposterior diameter > 55 mm
- Lactating, pregnant, or women planning or potentially becoming pregnant
- Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator
Kiket keres a vizsgálat
- 18 to 75 years with documented symptomatic PerAF (AF duration: 7 to 365 days), who were either refractory to or intolerant of at least one Class I or III antiarrhythmic drug and willing to provide informed consent.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The Third People's Hospital of Chengdu | Chengdu | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.