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

Atrial Fibrillation Clinical Trial

— AF-PACC-CRYO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311098
• Other study ID #: AF-PACC-CRYO
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2022
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• cryoablation
Treatment of atrial fibrillation with cryoablation catheters

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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