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The efficacy and safety of left atrial substrate modification of the cryoballoon ablation in persistent atrial fibrillation

The efficacy and safety of left atrial substrate modification of the cryoballoon ablation in persistent atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065626
Enrollment
Unknown
Registered
2022-11-10
Start date
2022-11-21
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

pulmonary vein isolation:pulmonary vein isolation
pulmonary vein isolation +left atrial ablation:pulmonary vein isolation +left atrial ablation

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Symptomatic persistent AF was confirmed by routine 12-lead electrocardiogram or 24-hour ambulatory electrocardiogram monitoring (HOLTER), and the duration was more than 7 days and less than 3 years; 2. First cryoablation of atrial fibrillation; 3. Age >= 18 years; 4. Exclusion of left atrial and left atrial appendage thrombus by transesophageal echocardiography (TEE). 5. Electrocardiogram or HOLTER can be performed regularly every 3 months after operation; 6. Patients and their families understand the purpose and steps of this study, voluntarily participate in this study and sign written informed consent; 7. Patients and their families are willing and able to follow the requirements of the research plan and other programs.

Exclusion criteria

Exclusion criteria: 1. Patients with paroxysmal atrial fibrillation; 2. Patients with persistent atrial fibrillation lasting for more than 3 years; 3. Patients who have undergone left atrial ablation or cardiac surgery (including occlusion of left atrial appendage); 4. Patients with intracardiac thrombus; 5. Patients with LVEF 55mm; 6. Previous diseases associated with surgery, including pre-existing pulmonary vein stents or pulmonary vein stenosis, pulmonary vein trunk diameter > 28mm, phrenic nerve paralysis, severe organic heart disease (such as artificial heart valve replacement, severe heart valvular disease, severe congenital heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy), etc. 7. Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary stent implantation occurred within three months before signing consent; any ischemic event (stroke or transient ischemic attack) occurred within 6 months before signing informed consent; 8. New York Heart Association (NYHA) III or IV congestive heart failure; 9. with any disease that prohibits long-term anticoagulation; 10. Active systemic infections; 11. Atrial fibrillation due to reversible causes, such as hyperthyroidism; 12. Women who are pregnant; 13. Life expectancy less than one year; 14. Participation in clinical trials of any other drugs, devices or biological agents currently or expected during the study period; 15. Patients with severe liver insufficiency or renal insufficiency; 16. Patients with poor compliance and unable to be reexamined and followed up on time.

Design outcomes

Primary

MeasureTime frame
Postoperative atrial fibrillation;

Secondary

MeasureTime frame
Blood biomarker;Thromboembolism;Bleeding;Cardiovascular death;All-cause mortality;Heart failure;Assessment in quality of life;

Countries

China

Contacts

Public ContactTong Liu

The Second Hospital of Tianjin Medical University

liutongdoc@126.com+86 13902183163

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 9, 2026