NCT07294742Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 8 Dec 2025
- Start date
- 6 Nov 2024
- Primary completion date
- 29 May 2025
- Lead sponsor
- The Third People's Hospital of Chengdu
- Diseases
- Atrial fibrillation
- NCT number
- NCT07294742
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 6 Nov 2024 to the primary completion date, 29 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 \[TEE\])
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third People's Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.