[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659233":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":33,"overallOfficials":33,"centralContacts":42,"locations":51,"responsibleParty":69,"collaborators":73,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":33,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":33,"studyType":91,"phases":33,"briefSummary":92,"conditions":93,"keywords":33,"overallStatus":95,"whyStopped":33,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Shenyang Northern Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Composite endpoint of 30-day postoperative complications","Including any of the following adverse events：\n\n1. Death (including all-cause mortality and cardiovascular death)；\n2. Stroke\u002F transient ischemic attack;\n3. Pericardial tamponade \u002F Pericardial Effusion (need drainage or surgical removal)；\n4. major vascular complications \u002F major bleeding events (resulting in death, blood transfusion, prolonged hospitalization, or surgical\u002Finterventional treatment)； 5) major vascular complications (requires repair, intervention, or blood transfusion); 6) Symptomatic pulmonary vein stenosis (requires intervention\u002F surgery); 7) atrioesophageal fistula\u002F esophageal injury;\n\n8）persistent phrenic nerve injury (persisting beyond 7 days following the index procedure); 9）Severe arrhythmia (requires cardioversion\u002Femergency drug treatment)","Within 30 days postoperatively",{"measure":14,"description":15,"timeFrame":16},"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.","At 6 months postoperatively",[18,22,26,29],{"measure":19,"description":20,"timeFrame":21},"Acute success rate of pulmonary vein isolation","Defined as the proportion of subjects with confirmed complete isolation of all pulmonary veins.","Intraoperative",{"measure":23,"description":24,"timeFrame":25},"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);\n2. Minor vascular access complications (without intervention\u002F surgery);\n3. Minor bleeding (without transfusion, surgical\u002Finterventional treatment);\n4. Asymptomatic pulmonary vein stenosis (without intervention);\n5. Non-serious cardiovascular and pulmonary medical device and\u002For procedure-related adverse events;\n6. medical device related adverse events (e.g., mild vascular irritation related to catheter manipulation; device performance anomaly without serious clinical sequelae)","Intraoperative\u002Fwithin 30 days postoperatively\u002Fat 6 months postoperatively",{"measure":27,"description":28,"timeFrame":21},"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.",{"measure":30,"description":31,"timeFrame":32},"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.).","From enrollment to the end of treatment at 6 months postoperatively",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","Cryoballoon ablation has become an initial therapy for patients with paroxysmal atrial fibrillation, owing to its advantages of procedural standardization, high intraoperative comfort, reliable pulmonary vein isolation, and favorable safety profile. The Nordica® balloon features a single-layer design, offering superior compliance compared to double-layer balloons. This facilitates transmural pulmonary vein isolation (PVI) and reduces the likelihood of segmental ablation and adjacent tissue injury. The balloon maintains an internal pressure of 3 psi or 5 psi with high leak resistance, a design that prevents displacement caused by sudden pressure spikes during ablation and minimizes failures in pulmonary vein isolation due to inadequate contact. Furthermore, the compliant design of the Nordica® balloon conforms better to pulmonary vein anatomy, enabling easy occlusion of the pulmonary veins without the need for additional pushing force. It has been approved for pulmonary vein isolation in this patient population. Previous studies have demonstrated the safety and efficacy of the Nordica® cryoballoon in the treatment of paroxysmal atrial fibrillation. Nevertheless, there is still a lack of multi-center, prospective real-world evidence on the long-term effectiveness, safety, procedural efficiency, and health economic value of the Nordica® cryoballoon in routine clinical practice Therefore, we aim to conduct a multi-center, prospective, single-arm, observational real-world study to assess the post-marketing safety, effectiveness, procedural efficiency, and health economic outcomes of the Nordica® cryoballoon for pulmonary vein isolation in patients with paroxysmal atrial fibrillation, with the goal of developing high-quality, evidence-based guidelines to inform its standardized use in clinical practice.","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.",[40],{"label":41,"type":33,"description":33,"interventionNames":33},"AF catheter ablation",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":33,"email":47},"Yaling Han","CONTACT","86-24-23922184","cardiology@163.com",{"name":49,"role":45,"phone":46,"phoneExt":33,"email":50},"Zulu Wang","wangzulu62@126.com",[52],{"facility":53,"status":33,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"General Hospital of Northern Theater Command","Shenyang","Liaoning","110000","China","CN",{"type":60,"coordinates":61},"Point",[62,63],123.43278,41.79222,{"lat":63,"lon":62},[66,68],{"name":44,"role":45,"phone":67,"phoneExt":33,"email":47},"+86-24-23922184",{"name":49,"role":45,"phone":33,"phoneExt":33,"email":50},{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Han Yaling","Prof.",[74,76],{"name":75,"class":6},"Tianjin Chest Hospital",{"name":77,"class":6},"The First Hospital of Jilin University","100659233","cryoballoon-pulmonary-vein-isolation-for-paroxysmal-atrial-fibrillation-100659233",false,"NCT07862972","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","Inclusion Criteria:\n\n1. Aged 18-75 years.\n2. Documented paroxysmal atrial fibrillation (PAF), eligible for AF catheter ablation, and scheduled to undergo a cryoballoon-based pulmonary vein isolation.\n3. Willing and able to complete all protocol-required study visits and assessments.\n4. Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1. Prior AF ablation (catheter-based), left atrial maze procedure, or any other pulmonary vein\u002Fleft atrial intervention;\n2. Left atrial (LA) diameter \\>55 mm, or severe valvular heart disease requiring surgical intervention;\n3. Left ventricular ejection fraction \\\u003C 40%;\n4. Stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), Myocardial infarction (MI), Any cardiac surgical or percutaneous cardiac procedure within the last three months;\n5. Left atrial\u002Fleft atrial appendage thrombus;\n6. Severe liver and\u002For renal insufficiency;\n7. With bleeding tendency, contraindication for anticoagulation, or inability to tolerate oral anticoagulant therapy.\n8. Pregnant or breastfeeding women;\n9. with cryoglobulinemia;\n10. Hypersensitivity reactions to contrast media;\n11. 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.).","ALL","18 Years","75 Years",{"count":89,"type":90},50,"ESTIMATED","OBSERVATIONAL","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.",[94],"Paroxysmal Atrial Fibrillation (PAF)","NOT_YET_RECRUITING","2026-09-30",{"date":98,"type":99},"2026-10-07","ACTUAL",{"date":101,"type":90},"2026-10-15",{"date":103,"type":90},"2027-10-30",{"name":5,"class":6},1]