Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation in the treatment of paroxysmal/short-course persistent atrial fibrillation.

Detailed Description
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The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation using the Medtronic Arctic Front AdvanceTM catheter in the treatment of paroxysmal/short-course persistent atrial fibrillation

Official Title
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Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old ≤ age ≤ 85 years old; Patients with paroxysmal/short-term persistent atrial fibrillation; Be able to understand the purpose of the research, voluntarily participate in the research and sign the informed consent. Exclusion Criteria: Echocardiography shows that the left atrium diameter is greater than or equal to 45mm; Preoperative CT or esophageal echocardiography suggests that there is a thrombus in the left atrium/left atrial appendage; Those who have undergone left atrial ablation or left atrial surgery; Those who have received simple left atrial appendage occlusion; New York heart function class (NYHA) class III or IV congestive heart failure or LVEF (%) less than 40%; Those who have undergone valve repair; Preoperative electrocardiogram or Holter confirmed the presence of typical atrial flutter or other supraventricular tachycardia (holding The duration is greater than 30 s); Secondary atrial fibrillation, including uncontrolled hyperthyroidism, acute alcoholism, cardiac surgery postoperative atrial fibrillation, etc.; History of acute coronary events or percutaneous coronary stent intervention within 6 months before enrollment; Those with a history of cardioverter-defibrillator (ICD) implantation or a history of cardiac resynchronization therapy (CRT); History of stroke or transient ischemic attack within 6 months before enrollment; Those with obvious bleeding tendency who cannot receive postoperative systemic anticoagulation; Severe structural heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.; Combined with other serious diseases, the life expectancy is less than 12 months; Women who are pregnant, breastfeeding and planning to become pregnant; Have participated in or are participating in clinical investigators of other drugs or devices within 3 months before enrollment; Other conditions assessed by the investigator to be unsuitable for inclusion in this study, such as persons with mental disorders or mental disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibule Group<br>Cryoablation | Device: cryoablation<br>* Treatment of atrial fibrillation with cryoablation catheters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year atrial fibrillation-free rate | Treatment success rate within 12 months after surgery (ie: no antiarrhythmic drug use, and no atrial fibrillation lasting ≥30s after a 3-month postoperative blank period to a 12-month postoperative follow-up). , AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) events). | 1-year | 
| pulmonary vein isolation rate | Immediate success rate of surgery: the percentage of subjects whose pulmonary veins were successfully electrically isolated at the end of surgery (including 30-minute observation time) to the total number of patients undergoing surgery. | Immediate |