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

Primary Purpose

Atrial Fibrillation, Persistent, Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)
catheter radiofrequency ablation(PVI)
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation, Persistent focused on measuring linear ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

linear ablation group

PVI group

Arm Description

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.

pulmonary vein isolation ablation alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

complications related to ablation
Tamponade, pericarditis and perforation following the ablation procedure

Full Information

First Posted
June 14, 2022
Last Updated
July 20, 2022
Sponsor
China National Center for Cardiovascular Diseases
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE, Beijing Hospital, Wuhan Asia Heart Hospital, Tianjin Medical University General Hospital, Fuwai Yunnan Cardiovascular Hospital, RenJi Hospital, Shenzhen Fuwai Hospital,Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05468528
Brief Title
Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation
Acronym
CLEAR AF II
Official Title
Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE, Beijing Hospital, Wuhan Asia Heart Hospital, Tianjin Medical University General Hospital, Fuwai Yunnan Cardiovascular Hospital, RenJi Hospital, Shenzhen Fuwai Hospital,Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent, Atrial Fibrillation
Keywords
linear ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
linear ablation group
Arm Type
Experimental
Arm Description
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.
Arm Title
PVI group
Arm Type
Other
Arm Description
pulmonary vein isolation ablation alone
Intervention Type
Procedure
Intervention Name(s)
catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)
Intervention Description
individualized stepwise linear ablation without pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
catheter radiofrequency ablation(PVI)
Intervention Description
pulmonary vein isolation
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation at 1 year
Description
Recurrent AF is defined as documented AF (through 12-lead ECG) episode lasting >30 seconds after a 3-month blanking period.
Time Frame
12 months after the ablation
Secondary Outcome Measure Information:
Title
complications related to ablation
Description
Tamponade, pericarditis and perforation following the ablation procedure
Time Frame
12 months after the ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: Sinus rhythm at the time of recruitment; Age less than 18 years old or older than 75 years; Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm; History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History; Left atrial thrombus recorded by ultrasound or CT; Combined with severe lung disease; Previous history of cardiac surgery; Patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment
Facility Information:
Facility Name
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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