NCT07862972Not yet recruiting
Cryoballoon Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Assessment of Pulmonary Vein Isolation Using the Cryoballoon in Paroxysmal Atrial Fibrillation: A Multi-center, Prospective Observational Clinical Study
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Shenyang Northern Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07862972
What you commit to
- Study type: Observational
- Planned participants: 50
- From Oct 2026 to the primary completion date, Jun 2027
- 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
- Prior AF ablation (catheter-based), left atrial maze procedure, or any other pulmonary vein/left atrial intervention;
Other illness
- 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.).
Lab values
- Left ventricular ejection fraction \< 40%;
Other
- Left atrial/left atrial appendage thrombus;
- Pregnant or breastfeeding women;
- with cryoglobulinemia;
Who the study is looking for
- 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.
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 |
|---|---|---|---|
| General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.