NCT07321002Toborzás még nem indult
PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation
Assessment of a Novel Shape-Adaptive Catheter With for Both Single-Shot and Large-Focal Pulsed Field Ablation the DePolar Mapping System in Persistent Atrial Fibrillation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 6.
Rövid összefoglaló (regiszter, angolul)
This clinical trial aims to evaluate the safety and efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field ablation (PFA) catheter (PFLotus, EnChannel Medical) integrated with a novel mapping system (DePolar, EnChannel Medical). The primary study objectives are to determine: * The incidence of serious procedure- or device-related adverse events within 7 days post-procedure (primary safety endpoint). * The clinical effectiveness of the integrated PFA and mapping system. * The ability of the novel PFA system to produce durable ablation lesions. PersAF patients will be treated under general anesthesia using the PFLotus PFA catheter (bipolar, biphasic waveform; 850 V, 60 μs per pulse). Ablation targets, including PVI and other lesions (left atrial posterior wall, mitral isthmus, cavotricuspid isthmus, and superior vena cava), will be accessed under fluoroscopic and DePolar mapping system guidance. Participants will: 1. Receive PVI, focal, and linear ablation using the PFLotus PFA catheter and DePolar mapping system under general anesthesia; 2. Be monitored for serious procedure- or device-related adverse events during the first 7 days post-procedure; 3. Undergo repeat electrophysiological mapping at 3 months to assess lesion durability; 4. Attend scheduled follow-up visits at 7 days, 30 days, and 3, 6, and 12 months post-ablation. Atrial arrhythmia recurrence will be assessed via 12-lead electrocardiography at each visit and by 24-hour or 7-day Holter monitoring at the 6- and 12-month visits.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 35 (tervezett)
- Első benyújtás
- 2025. dec. 9.
- Kezdés
- 2025. dec. 22.
- Elsődleges befejezés
- 2026. jún. 1.
- Fő szponzor
- The Third People's Hospital of Chengdu
- Betegségek
- Pitvarfibrilláció
- NCT-szám
- NCT07321002
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 35
- 2025. dec. 22. és az elsődleges befejezés (2026. jún. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálatot írja le, nem a te helyzetedet.
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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
- 1\. Aged 18-75 years (inclusive). 2. Diagnosis of symptomatic persistent atrial fibrillation (AF), defined as documented AF episodes exceeding 7 days or a documented history of persistent AF. Additionally, at least one of the following criteria must be met within 365 days prior to enrollment:
- A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period.
- Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF.
- 3\. Documented failure or intolerance to at least one Class I or Class III antiarrhythmic drug (AAD).
- 4\. Willingness to participate in the trial, ability to comply with protocol-specified follow-up assessments, and provision of written informed consent.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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