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NCT Number: NCT07122336

Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation

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.

Recruiting

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

PVI

Procedure

PVI

PWI

Procedure

PWI

EGM

Procedure

EGM

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

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

  4. 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)

    Time frame: 12 months

  5. 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

    Time frame: 12 months

  6. freedom from any documented symptomatic atrial fibrillation/flutter/tachycardia episodes (>30 seconds) after assessment of all ablation procedures at final follow-up, excluding the initial 3-month blanking period.

    Time frame: 12 months

  7. Procedure time / Fluoroscopy time / ablation time

    Time frame: 12 months

  8. Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality.

    Time frame: 12 months

  9. Quality of life assessments during ≥12-month follow-up (AFEQT)

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mu Qin

CONTACT

[email protected]

13052320103

Xumin Hou

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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