Termination of Persistent Atrial Fibrillation by Catheter Ablation

Atrial Fibrillation Clinical Trial

Official title:

A Prospective, Multicenter, Cohort Study of Termination of Persistent Atrial Fibrillation by Catheter Ablation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04958928
• Other study ID #: Termination-AF
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: July 2021
• Source: Shanghai Chest Hospital
• Contact: Qin Mu, MD
• Phone: +8613052320103
• Email: qinmuae[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged 18 to 80 years old; 2. Persistent AF; 3. Nonresponse or intolerance to =1 antiarrhythmic drug.

Exclusion Criteria:

1. With uncontrolled congestive heart failure;

2. Having significant valvular disease and/or prosthetic heart valve(s);

3. With myocardial infarction or stroke within 6 months of screening;

4. With Significant congenital heart disease;

5. Ejection fraction was <40% measured by echocardiography;

6. Allergic to contrast media;

7. Contraindication to anticoagulation medications;

8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;

10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Any cardiac surgery within the past 2 months; 14. Poor general health; 15.Life expectancy less than 6 months.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
All patients received radiofrequncy ablation.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Beijing Chao Yang Hospital, Ruijin Hospital, The First Affiliated Hospital of Dalian Medical University, The Third People's Hospital of Chengdu, The Third Xiangya Hospital of Central South University, Wuhan Central Hospital, Xiamen Cardiovascular Hospital, Xiamen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrence rate	AF recurrence is defined as presence of documented AF episodes of 30 recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.	12 months