Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation

Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06739512

Enrollment

600

Registered

2024-12-18

Start date

2024-12-25

Completion date

2026-12-01

Last updated

2024-12-18

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

Conditions

Atrial Fibrillation (AF)

Keywords

ablation, atrial fibrillation

Brief summary

This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.

Interventions

PROCEDUREExtensive Electro-Anatomical Guided Ablation

Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.

PROCEDUREAnatomical Guided Ablation

Ablation using PFA. Guided by anatomical landmarks without potential mapping

PROCEDUREElectrogram Guided Ablation

Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.

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 and Quality of Life Enhancement.	From enrollment to completion of follow-up（at least 12 months）	Improvement in clinical symptoms (EHRA score) and quality of life measurements (Short Form 36 HealthSurvey).
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