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

NCT ID: NCT05311098

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-05-01

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vestibule Group

Cryoablation

Group Type: EXPERIMENTAL

cryoablation

Intervention Type: DEVICE

Treatment of atrial fibrillation with cryoablation catheters

Interventions

cryoablation

Treatment of atrial fibrillation with cryoablation catheters

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jun Zhang, M.D.

Role: primary

zhangjun_njmu2011@163.com

+8615000420881

Other Identifiers

AF-PACC-CRYO

Identifier Type: -

Identifier Source: org_study_id