This post-marketing, multi-center, prospective, single-arm, observational study will be conducted across 3 clinical sites in China and enroll no more than 50 patients with paroxysmal atrial fibrillation. After clinical site initiation, each study site was permitted to enroll up to 2 roll-in cases to allow operators to familiarize themselves with the Nordica® cryoballoon and standardize procedural techniques. A competitive enrollment method will be adopted to recruit up to 50 patients with paroxysmal atrial fibrillation. The Nordica® cryoballoon will be employed for pulmonary vein isolation during the procedure. A 6-month follow-up assessment is scheduled at the following time points: the index hospitalization period (days 0-3), and post-procedure follow-up time points at 30 days, 3 months, and 6 months.
Aged 18-75 years.
Documented paroxysmal atrial fibrillation (PAF), eligible for AF catheter ablation, and scheduled to undergo a cryoballoon-based pulmonary vein isolation.
Willing and able to complete all protocol-required study visits and assessments.
Ability to understand the study procedures and provide written informed consent.
Prior AF ablation (catheter-based), left atrial maze procedure, or any other pulmonary vein/left atrial intervention;
Left atrial (LA) diameter >55 mm, or severe valvular heart disease requiring surgical intervention;
Left ventricular ejection fraction < 40%;
Stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), Myocardial infarction (MI), Any cardiac surgical or percutaneous cardiac procedure within the last three months;
Patients (aged 18-75 years) was documented paroxysmal atrial fibrillation (PAF), eligible for AF catheter ablation, and scheduled to undergo a cryoballoon-based pulmonary vein isolation.
Cohort
Prospective
Not listed
Composite endpoint of 30-day postoperative complications
Including any of the following adverse events： 1. Death (including all-cause mortality and cardiovascular death)； 2. Stroke/ transient ischemic attack; 3. Pericardial tamponade / Pericardial Effusion (need drainage or surgical removal)； 4. major vascular complications / major bleeding events (resulting in death, blood transfusion, prolonged hospitalization, or surgical/interventional treatment)； 5) major vascular complications (requires repair, intervention, or blood transfusion); 6) Symptomatic pulmonary vein stenosis (requires intervention/ surgery); 7) atrioesophageal fistula/ esophageal injury; 8）persistent phrenic nerve injury (persisting beyond 7 days following the index procedure); 9）Severe arrhythmia (requires cardioversion/emergency drug treatment)
Incidence of freedom from atrial arrhythmia at 6 months postoperatively
Defined as the proportion of subjects free from any documented atrial tachyarrhythmia - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds - occurring. These episodes must be confirmed by 12-lead electrocardiogram (ECG) and seven-day Holter monitoring following a 6-month period post-ablation.
Acute success rate of pulmonary vein isolation
Defined as the proportion of subjects with confirmed complete isolation of all pulmonary veins.
The extended major safety endpoints, minor adverse events, and other medical device adverse event or procedure-related adverse event
1. Transient phrenic nerve palsy (requiring brief intervention therapy, recovered prior to discharge); 2. Minor vascular access complications (without intervention/ surgery); 3. Minor bleeding (without transfusion, surgical/interventional treatment); 4. Asymptomatic pulmonary vein stenosis (without intervention); 5. Non-serious cardiovascular and pulmonary medical device and/or procedure-related adverse events; 6. medical device related adverse events (e.g., mild vascular irritation related to catheter manipulation; device performance anomaly without serious clinical sequelae)
Procedure efficiency
Will be described using (mean, median, and distribution): total procedure room time, procedure time, pulmonary vein isolation time, left atrial dwell time, the length of hospital stay (LOS), ablation time, the number of ablation applications, time to isolation (TTI), and fluoroscopy time, fluoroscopy dose.
Health economics
Will be described using (mean and distribution): direct medical costs of subjects (procedure cost, device cost, examination costs, medication costs, hospitalization costs, etc.).
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Shenyang Northern Hospital
Lead sponsor
Tianjin Chest Hospital
Collaborator
The First Hospital of Jilin University
Collaborator
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