Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation (CLEAR AF II)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Atrial Fibrillation, Persistent
• Intervention / Treatment: Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation); Procedure: catheter radiofrequency ablation(PVI)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: linear ablation group; 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.	Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation); individualized stepwise linear ablation without pulmonary vein isolation
Other: PVI group; pulmonary vein isolation ablation alone	Procedure: catheter radiofrequency ablation(PVI); pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications related to ablation	Tamponade, pericarditis and perforation following the ablation procedure	12 months after the ablation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: linear ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2021-1627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No