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Study of improvement on left atrial matrix of paroxysmal atrial fibrillation patients by cryoablation treatment using cryoballoon

Study of improvement on left atrial matrix of paroxysmal atrial fibrillation patients by cryoablation treatment using cryoballoon

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037507
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

paroxysmal atrial fibrillation

Interventions

Case series:cryoablation of PV

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years old; 2. paroxysmal atrial fibrillation patients accompanied by symptoms; 3. patients suffering from paroxysmal atrial fibrillation who has taken no less than one kind of Class I or III antiarrhythmic drugs but the treatment effect is not good or has no good result, or who is drug intolerance, or who is not willing to take antiarrhythmic drugs; 4. Be able to understand the purpose of the experiment, participate in the experiment voluntarily and has signed the informed consent file.

Exclusion criteria

Exclusion criteria: 1) Echocardiography showed the anteroposterior diameter of the left atrium >=55 mm; 2) Preoperative CT or transesophageal echocardiography showed thrombus in left atrium / left atrial appendage; 3) Patients who had undergone left atrial ablation or left atrial surgery; 4) NYHA grade III or IV congestive heart failure or LVEF (%) less than 40%; 5) Patients who have undergone valve repair operation; 6) Secondary atrial fibrillation (AF) includes hyperthyroidism without effective control of AF after cardiac surgery for acute alcoholism; 7) There is a history of acute coronary events or percutaneous coronary intervention within 6 months before enrollment; 8) Patients with a history of ICD implantation or cardiac resynchronization therapy (CRT); 9) There is a history of stroke or transient ischemic attack within 3 months before enrollment; 10) Patients with obvious bleeding tendency and unable to accept postoperative systemic anticoagulation; 11) Severe organic heart diseases include moderate to severe mitral insufficiency or stenosis, previous myocardial infarction and hypertrophic cardiomyopathy; 12) The life expectancy of patients with other serious diseases is less than 12 months; 13) Women during pregnancy, lactation and preparation for pregnancy; 14) Those who have participated in or are participating in clinical research of other drugs or devices within 3 months before enrollment; 15) Other cases that are not suitable for inclusion in this study assessed by researchers, such as mental or psychological disorders.

Design outcomes

Primary

MeasureTime frame
treatment success rate within 12 months after operation;

Countries

China

Contacts

Public ContactNie, Zhenning

Zhongshan Hospital Affiliated to Fudan University

Nie.zhenning@zs-hospital.sh.cn+86 13681973682

Outcome results

None listed

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