Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation (AF-PACC-CRYO)

Tongji University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Device: cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05311098

AF-PACC-CRYO

Details and patient eligibility

About

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.

Full description

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years old ≤ age ≤ 85 years old;
2. Patients with paroxysmal/short-term persistent atrial fibrillation;
3. Be able to understand the purpose of the research, voluntarily participate in the research and sign the informed consent.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Vestibule Group

Experimental group

Description:

Cryoablation

Treatment:

Device: cryoablation