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

February 11, 2025 updated by: Xu Liu, Shanghai Chest Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from any documented AF/AT episode
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from any documented AF episode
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Periprocedural complications,including stroke, PV stenosis, cardiac perforation, oesophageal injury and death.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Chest Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Yangpu District Central Hospital
Jinshan Hospital Affiliated to Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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