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A prospective, multi-center, single-group target value method to evaluate the effectiveness and safety of cryoablation in the treatment of paroxysmal atrial fibrillation

A prospective, multi-center, single-group target value method to evaluate the effectiveness and safety of cryoablation in the treatment of paroxysmal atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036093
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-11-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Atrial fibrillation

Interventions

Case series:Cryoablation

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 75 years old; 2) Patients with paroxysmal atrial fibrillation with symptoms; 3) Those with symptomatic atrial fibrillation who have taken at least one type I or III antiarrhythmic drug treatment effect or cannot tolerate drug treatment; 4) Able to understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Echocardiography shows that the anteroposterior diameter of the left atrium >=50 mm; 2) Preoperative CT or esophageal echocardiography revealed thrombosis in the left atrium/left atrial appendage; 3) Those who have received left atrial ablation or left atrial surgery; 4) Those who have undergone left atrial appendage occlusion or are planning to undergo one-stop atrial fibrillation ablation and left atrial appendage occlusion; 5) New York Heart Function Classification (NYHA) grade III or IV congestive heart failure or LVEF (%) less than 40%; 6) Those who have undergone valve repair; 7) Patients with typical atrial flutter or other supraventricular tachycardia (duration greater than 30 s) confirmed by ECG or Holter before operation; 8) Secondary atrial fibrillation, including ineffective control of hyperthyroidism, acute alcoholism, atrial fibrillation after cardiac surgery, etc.; 9) A history of acute coronary events or a history of percutaneous coronary stent intervention within 6 months before enrollment; 10) Those who have a history of cardioverter defibrillator (ICD) implantation or cardiac resynchronization therapy (CRT); 11) A history of stroke or transient ischemic attack within 6 months before enrollment; 12) Those who have obvious bleeding tendency and cannot accept postoperative systemic anticoagulation; 13) Severe organic heart disease, including moderate to severe mitral regurgitation or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.; 14) Combined with other serious diseases, life expectancy is less than 12 months; 15) Women who are pregnant, breastfeeding and preparing to become pregnant; 16) Those who have participated or are participating in clinical research of other drugs or devices within 3 months before enrollment; 17) Other conditions assessed by the investigator that are not suitable for inclusion in this study, such as mental or psychological disorders.

Design outcomes

Primary

MeasureTime frame
12-lead ECG;Holter;Transesophageal ultrasonography;Echocardiography;Major organ bleeding;

Secondary

MeasureTime frame
International normalized ratio;Left ventricular ejection fraction;New York Heart Association;

Countries

China

Contacts

Public ContactYawei Xu

Shanghai Tenth People's Hospital

xuyawei@tongji.edu.cn+86 18917683030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026