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

N

National Center for Cardiovascular Diseases

Status

Not yet enrolling

Conditions

Atrial Fibrillation, Persistent
Atrial Fibrillation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05468528
2021-1627

Details and patient eligibility

About

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.

Full 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.

Enrollment

207 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

207 participants in 2 patient groups

linear ablation group
Experimental group
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.
Treatment:
Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)
PVI group
Other group
Description:
pulmonary vein isolation ablation alone
Treatment:
Procedure: catheter radiofrequency ablation(PVI)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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