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Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation, Persistent

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Catheter ablation
Sponsored by
Xu Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation, Persistent focused on measuring catheter ablation, atrial fibrillation, Driver ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines; Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment. Exclusion Criteria: Uncontrolled congestive heart failure; History of severe valve disease and/or prosthetic valve replacement; Myocardial infarction or stroke within 6 months; Severe congenital heart disease; EF <40%; Contrast agent allergy; The use of anticoagulant drugs is contraindicated; Severe lung disease; Left atrial thrombus confirmed by preoperative esophageal ultrasound; Contraindications for cardiac catheterization; Atrial fibrillation ablation; Have performed any cardiac surgery within 2 months; Poor general health; Life expectancy < 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    RA group

    Control group

    Arm Description

    The RA group received adjunctive right atrial ablation in addition to left side ablation.

    The control group received left side ablation only.

    Outcomes

    Primary Outcome Measures

    Atrial fibrillation recurrence
    any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure.

    Secondary Outcome Measures

    Atrial fibrillation/atrial tachycardia recurrence
    any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs treatment at 12 months after a single procedure or freedom from any AF episodes lasting more than 30 seconds occurring after the blanking period without the use of anti-arrhythmic drugs at the end of study follow-up after a single procedure.

    Full Information

    First Posted
    May 9, 2023
    Last Updated
    May 31, 2023
    Sponsor
    Xu Liu
    Collaborators
    The Third Xiangya Hospital of Central South University, Yangpu District Central Hospital Affiliated to Tongji University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05883722
    Brief Title
    Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation
    Official Title
    Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xu Liu
    Collaborators
    The Third Xiangya Hospital of Central South University, Yangpu District Central Hospital Affiliated to Tongji University

    4. Oversight

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.
    Detailed Description
    Long-term persistent atrial fibrillation (PerAF) may induce right atrial (RA) enlargement and subsequently atrial functional tricuspid regurgitation (AF-TR) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. Enlarged RA and significant AF-TR may aggravate atrial remodeling and contribute to AF sustaining. Previous studies showed that RA enlargement was closely related to the recurrence of AF after catheter ablation. However, unlike the left atrium, the RA mechanism has been poorly studied and generally excluded from the therapeutic target. In an animal model of right heart disease, the RA enlargement associated with re-entrant activity serves as the prominent mechanism of AF genesis. Using sophisticated mapping techniques, recent study has confirmed that up to one-third of AF drivers are located in the right atrium. Furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven AF have concomitant RA enlargement. Therefore, it is plausible to hypothesize that the presence of RA enlargement represents the necessity of adjunctive RA ablation. Currently, the value and timing of RA intervention are still under debate. Therefore, the purpose of the present study was to testify whether patients with PerAF and RA enlargement may benefit from adjunctive RA ablation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Persistent
    Keywords
    catheter ablation, atrial fibrillation, Driver ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RA group
    Arm Type
    Experimental
    Arm Description
    The RA group received adjunctive right atrial ablation in addition to left side ablation.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The control group received left side ablation only.
    Intervention Type
    Procedure
    Intervention Name(s)
    Catheter ablation
    Intervention Description
    The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation
    Primary Outcome Measure Information:
    Title
    Atrial fibrillation recurrence
    Description
    any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Atrial fibrillation/atrial tachycardia recurrence
    Description
    any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs treatment at 12 months after a single procedure or freedom from any AF episodes lasting more than 30 seconds occurring after the blanking period without the use of anti-arrhythmic drugs at the end of study follow-up after a single procedure.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines; Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment. Exclusion Criteria: Uncontrolled congestive heart failure; History of severe valve disease and/or prosthetic valve replacement; Myocardial infarction or stroke within 6 months; Severe congenital heart disease; EF <40%; Contrast agent allergy; The use of anticoagulant drugs is contraindicated; Severe lung disease; Left atrial thrombus confirmed by preoperative esophageal ultrasound; Contraindications for cardiac catheterization; Atrial fibrillation ablation; Have performed any cardiac surgery within 2 months; Poor general health; Life expectancy < 6 months.

    12. IPD Sharing Statement

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    Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

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