Cryoballoon Procedure for Paroxysmal Atrial Fibrillation in China
Observes how a cryoballoon procedure works in adults with paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Cryoballoon Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Key facts
- Where
- Shenyang, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07862972, who can take part
Where in China
- General Hospital of Northern Theater CommandShenyang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenyang Northern Hospital
- Trial code
- NCT07862972
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
Assessment of Pulmonary Vein Isolation Using the Cryoballoon in Paroxysmal Atrial Fibrillation: A Multi-center, Prospective Observational Clinical Study
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.
Inclusion: 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.
Exclusion: 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; Stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), Myocardial infarction (MI), Any cardiac surgical or percutaneous cardiac procedure within the last three months; Severe liver and/or renal insufficiency; With bleeding tendency, contraindication for anticoagulation, or inability to tolerate oral anticoagulant therapy; Hypersensitivity reactions to contrast media; Any factor that, in the investigator's judgment, renders the patient unsuitable for participation (such as mental illness, or inability to complete follow-up, etc.); Left ventricular ejection fraction < 40%; Left atrial/left atrial appendage thrombus; Pregnant or breastfeeding women; with cryoglobulinemia.