Clinical trial NCT05468528: Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation
Official title: Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Atrial Fibrillation
Keywords: linear ablation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
name: Beijing Hospital
name: Wuhan Asia Heart Hospital
name: Tianjin Medical University General Hospital
name: Fuwai Yunnan Cardiovascular Hospital
name: RenJi Hospital
name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2022-07-21
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from atrial fibrillation at 1 year
timeFrame: 12 months after the ablation
Secondary outcomes:
measure: complications related to ablation
timeFrame: 12 months after the ablation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
References: