Clinical trial NCT05311098: Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
Official title: Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: 1-year atrial fibrillation-free rate
timeFrame: 1-year
measure: pulmonary vein isolation rate
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References: