Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation

NCT ID: NCT07122336

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2026-12-31

Brief Summary

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The design of this study is an intervention, randomized, controlled study and contains three randomized groups:(1)PVI group;(2)PVI+PWI group;(3)PVI+PWI+EGM group.

Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PVI group

PVI

Group Type SHAM_COMPARATOR

PVI

Intervention Type PROCEDURE

PVI

PVI+ PWI group

PVI+ PWI

Group Type EXPERIMENTAL

PVI

Intervention Type PROCEDURE

PVI

PWI

Intervention Type PROCEDURE

PWI

PVI+ PWI+EGM group

PVI+ PWI+EGM

Group Type EXPERIMENTAL

PVI

Intervention Type PROCEDURE

PVI

PWI

Intervention Type PROCEDURE

PWI

EGM

Intervention Type PROCEDURE

EGM

Interventions

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PVI

PVI

Intervention Type PROCEDURE

PWI

PWI

Intervention Type PROCEDURE

EGM

EGM

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. First-time ablation for persistent atrial fibrillation (PsAF)
3. Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
4. Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
5. Documented PsAF episode: At least one recorded PsAF episode within the last 2 years prior to enrollment, confirmed by: ECG,Holter monitorin, Loop recorder, Telemetry, Transtelephonic monitoring (TTM),Implantable device
6. Ability and willingness to provide written informed consent
7. Compliance with all study follow-up requirements

Exclusion Criteria

1. Paroxysmal AF: Episodes lasting \<7 days (or requiring pharmacologic/electrical cardioversion \<7 days)
2. Long-standing persistent AF: Continuous AF duration \>3 years
3. No prior attempt/pursuit of cardioversion or sinus rhythm maintenance
4. Contraindications to systemic anticoagulation
5. Pregnancy
6. Advanced renal or hepatic failure
7. Severe valvular heart disease or cyanotic congenital heart disease
8. Hypertrophic cardiomyopathy (HCM)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Liu

Doctor Liu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mu Qin

Role: CONTACT

13052320103

Xumin Hou

Role: CONTACT

Facility Contacts

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Mu Qin

Role: primary

13052320103

Other Identifiers

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OAPWAF

Identifier Type: -

Identifier Source: org_study_id

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