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Cryoballoon Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Sponsor: Shenyang Northern Hospital
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.
Official title: Assessment of Pulmonary Vein Isolation Using the Cryoballoon in Paroxysmal Atrial Fibrillation: A Multi-center, Prospective Observational Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-10-15
Completion Date
2027-10-30
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Locations (1)
General Hospital of Northern Theater Command
Shenyang, Liaoning, China