Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— CLEAR AF II  

Official title:

Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05468528
• Other study ID #: 2021-1627
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. The participants will be randomized to the linear ablation group and PVI ablation group with a 2:1 ratio. the follow-up period is 12 months. The primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.

Description:

Pulmonary vein isolation is recommended as the cornerstone of catheter ablation of atrial fibrillation by current guidelines, However, meta-analysis suggests that the success rate of continuous pulmonary vein isolation for persistent atrial fibrillation is only 43%. Therefore, in addition to pulmonary vein isolation, further research on substrate modification in the treatment of atrial fibrillation is particularly important.

Based on our previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 207
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy.

• patients agreeing to be enrolled, with the informed consent signed

Exclusion Criteria:

1. Sinus rhythm at the time of recruitment;

2. Age less than 18 years old or older than 75 years;

3. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm;

4. History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History;

5. Left atrial thrombus recorded by ultrasound or CT;

6. Combined with severe lung disease;

7. Previous history of cardiac surgery;

8. Patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

Procedure:
• catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)
individualized stepwise linear ablation without pulmonary vein isolation
• catheter radiofrequency ablation(PVI)
pulmonary vein isolation

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (9)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Beijing Hospital, First Affiliated Hospital, Sun Yat-Sen University, Fuwai Yunnan Cardiovascular Hospital, RenJi Hospital, Shenzhen Fuwai Hospital,Chinese Academy of Medical Sciences, Tianjin Medical University General Hospital, Wuhan Asia Heart Hospital, ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation at 1 year	Recurrent AF is defined as documented AF (through 12-lead ECG) episode lasting >30 seconds after a 3-month blanking period.	12 months after the ablation
Secondary	complications related to ablation	Tamponade, pericarditis and perforation following the ablation procedure	12 months after the ablation