Comparative Efficacy and Safety of Extensive Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in Persistent Atrial Fibrillation

Comparative Efficacy and Safety of Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in the Treatment of Persistent Atrial Fibrillation: A Randomized Controlled Trial

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06745167

Enrollment

600

Registered

2024-12-20

Start date

2025-01-01

Completion date

2026-12-31

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation, pulsed field ablation, radiofrequency ablation

Brief summary

This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.

Interventions

PROCEDUREPulsed field ablation

Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation.

PROCEDURERadiofrequency ablation alone

Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.

Exclusion criteria

1. Major valvular diseases needing surgical intervention. 2. Presence of a left atrial thrombus on recent imaging. 3. Recent myocardial infarction or severe heart failure (LVEF ≤ 30%). 4. Current Severe Infection.

Design outcomes

Primary

Measure	Time frame	Description
Freedom from Atrial Arrhythmia Recurrence at 12 Months	12 months after ablation procedure	Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.

Secondary

Measure	Time frame	Description
Procedural Safety	From enrollment to completion of follow-up（at least 12 months）	Incidence of procedural complications such as esophageal injury and pulmonary vein stenosis.
Symptom Relief (EHRA scores)	From enrollment to completion of follow-up（at least 12 months）	Improvement in clinical symptoms (EHRA scores)
Quality of Life (Short Form 36 Health Survey).	From enrollment to completion of follow-up（at least 12 months）	quality of life measurements (Short Form 36 Health Survey).
Atrial Fibrillation Burden Reduction	From enrollment to completion of follow-up（at least 12 months）	Reduction in atrial fibrillation burden assessed through follow-up evaluations.

Countries

China

Contacts

Primary ContactXu Liu, MD

drliuxu@126.com+86 021-22200000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026