NCT05468528

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

June 14, 2022

Last Update Submit

July 20, 2022

Conditions

Atrial Fibrillation, PersistentAtrial Fibrillation

Keywords

linear ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • complications related to ablation

    12 months after the ablation

Study Arms (2)

linear ablation group

EXPERIMENTAL

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)

PVI group

OTHER

pulmonary vein isolation ablation alone

Procedure: catheter radiofrequency ablation(PVI)

Interventions

catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)PROCEDURE

individualized stepwise linear ablation without pulmonary vein isolation

linear ablation group
catheter radiofrequency ablation(PVI)PROCEDURE

pulmonary vein isolation

PVI group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy.
  • patients agreeing to be enrolled， with the informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

July 21, 2022

Study Start

August 1, 2022

Primary Completion

May 1, 2024

Study Completion

July 1, 2024

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

CN(1)