NCT07122336

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 16, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 14, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 17, 2025

Last Update Submit

August 13, 2025

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat

    12 months

Secondary Outcomes (9)

  • Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months

    12 months

  • Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure

    12 months

  • The atrial fibrillation burden among study groups at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs.

    12 months

  • Freedom from any documented atrial arrhythmia episodes lasting >30 seconds at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs (AADs)

    12 months

  • Freedom from any documented sustained atrial arrhythmia episodes lasting >7 days at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without antiarrhythmic drug therapy

    12 months

  • +4 more secondary outcomes

Study Arms (3)

PVI group

SHAM COMPARATOR

PVI

Procedure: PVI

PVI+ PWI group

EXPERIMENTAL

PVI+ PWI

Procedure: PVIProcedure: PWI

PVI+ PWI+EGM group

EXPERIMENTAL

PVI+ PWI+EGM

Procedure: PVIProcedure: PWIProcedure: EGM

Interventions

PVIPROCEDURE

PVI

PVI groupPVI+ PWI groupPVI+ PWI+EGM group
PWIPROCEDURE

PWI

PVI+ PWI groupPVI+ PWI+EGM group
EGMPROCEDURE

EGM

PVI+ PWI+EGM group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • First-time ablation for persistent atrial fibrillation (PsAF)
  • Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
  • Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
  • 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
  • Ability and willingness to provide written informed consent
  • Compliance with all study follow-up requirements

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mu Qin

CONTACT

13052320103qinmuae@163.com

Xumin Hou

CONTACT

houxumin@shchest.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Liu

Study Record Dates

First Submitted

July 17, 2025

First Posted

August 14, 2025

Study Start

July 16, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

August 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)