A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

NCT07590661 | Not Yet Recruiting

• 1 other identifier: EP-CP-IIS-010
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 12-month atrial fibrillation (AF) ablation success rate

  Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)

  12 months post-procedure

Secondary Outcomes (10)

• Acute pulmonary vein ablation success rate and superior vena cava isolation rate.

  Immediately post-procedure

• Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)

  Immediately post-procedure

• Procedure-related time

  Immediately post-procedure

• Early recurrence rate of atrial arrhythmia (within the blanking period)

  Within 3 months post-procedure

• Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.

  Within 12 months post-procedure

Study Arms (2)

superior vena cava isolation

EXPERIMENTAL

Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation and left atrial posterior wall isolation will be conducted in the experimental group.

Procedure: superior vena cava isolation

superior vena cava and left atrial posterior wall isolation

ACTIVE COMPARATOR

Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava and left atrial posterior wall isolation will be carried out in the control group.

Procedure: superior vena cava isolation; Procedure: Abnormal left atrial substrate

Interventions

superior vena cava isolation PROCEDURE

Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.

superior vena cava and left atrial posterior wall isolation; superior vena cava isolation

Abnormal left atrial substrate PROCEDURE

Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group.

superior vena cava and left atrial posterior wall isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years.
• Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days.
• Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

You may not qualify if:

• Atrial fibrillation is secondary to thyroid disease or other reversible factors.
• Evidence of left atrial or left atrial appendage thrombus on imaging examination.
• Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
• Left ventricular ejection fraction \<40% or New York Heart Association (NYHA) class III/IV.
• Left atrial anteroposterior diameter \>55 mm.
• Unstable angina.
• Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
• Previous catheter ablation or surgical ablation for atrial fibrillation.
• History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
• Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
• Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
• Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
• Active systemic infection.
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or history of renal dialysis.
• Severe hepatic dysfunction.

Sponsors & Collaborators

• Hangzhou Dinova EP Technology Co., Ltd: lead

Study Sites (1)

Fuwai Yunnan Hospital

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

GUODONG NIU

CONTACT

+86 0871-68279999; guodniu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 15, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)