Cryoballoon Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Composite endpoint of 30-day postoperative complications — Within 30 days postoperatively
  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 — 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.

Trial sites (1)

More Shenyang Northern Hospital trials in China

Other trials for the same condition