Recurrent Persistent Atrial Fibrillation:In-situ Ablation Vs Extensive Ablation

A Randomized Control Study of Repeat In-situ Ablation Versus Extensive Ablation for Patients with Recurrent Persistent Atrial Fibrillation

This is an open label, randomized parallel control clinical trial, to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.

Study Overview

• Status: Completed
• Conditions: Recurrent Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Extra-PV extensive ablation; Procedure: Repeat same PVI and linear ablation as the first procedure

Detailed Description

This is an open label, randomized parallel control clinical trial. Patients with recurrent persistent atrial fibrillation are 1:1 randomized into EXT group(Extra-PV extensive ablation) and IN-SITU group(Repeat same PVI and linear ablation as the first procedure). Postoperative recurrence rate and other indicators are analyzed to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older; 2) Diagnosed as recurrent PerAF according to the latest clinical guidelines; 3) Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment; 4) the first ablation procedure was PVI and linear ablation; 5) consented to receive radiofrequency catheter ablation.

Exclusion Criteria:

• 1) Recurrent atrial flutter/atrial tachycardia; 2) The first ablation procedure included extra-PV substrate ablation; 3) The first low voltage area>30%; 4) Serious complications during the first procedure; 5) The first ablation was paroxysmal atrial fibrillation. 6) Uncontrolled congestive heart failure; 7) History of severe valve disease and/or prosthetic valve replacement; 8) Left atrial thrombus confirmed by preoperative esophageal ultrasound; 9) Severe congenital heart disease; 10) Severe lung disease; 11) Left atrial diameter ≥60mm; 12) Contraindications for cardiac catheterization; 13) Myocardial infarction or stroke within 6 months; 14) Contrast agent allergy; 15) The use of anticoagulant drugs is contraindicated; 16) Have performed any cardiac surgery within 2 months;17) life expectancy is less than one year, including factors such as physical inability to tolerate ablation or unstable disease conditions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXT group	Procedure: Extra-PV extensive ablation; Extra-PV extensive ablation; Procedure: Repeat same PVI and linear ablation as the first procedure; Repeat same PVI and linear ablation as the first procedure
Sham Comparator: IN-SITU group	Procedure: Extra-PV extensive ablation; Extra-PV extensive ablation; Procedure: Repeat same PVI and linear ablation as the first procedure; Repeat same PVI and linear ablation as the first procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from any documented AF/AT episode	Freedom from any documented AF/AT episode lasting more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from any documented AF episode	Freedom from any documented AF episode lasting more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication	12 months
Any documented AT episode	Any documented AT episode lasting more than 30 seconds excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication	12 months
Periprocedural complications	Periprocedural complications,including stroke, PV stenosis, cardiac perforation, oesophageal injury and death.	12 months

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: Shanghai Yangpu District Central Hospital; Jinshan Hospital Affiliated to Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Arrhythmias, Cardiac; Recurrence; Atrial Fibrillation
• Other Study ID Numbers: RIEAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No