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

Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: superior vena cava isolation; Procedure: Abnormal left atrial substrate

Detailed Description

No other detailed description.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GUODONG NIU; Phone Number: +86 0871-68279999; Email: guodniu@163.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Fuwai Yunnan Hospital
      • Contact: Guodong Niu, PhD; Phone Number: +860871-68279999; Email: guodniu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Older than 18 years.
2. 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.
3. 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.

Exclusion Criteria:

1. Atrial fibrillation is secondary to thyroid disease or other reversible factors.
2. Evidence of left atrial or left atrial appendage thrombus on imaging examination.
3. Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
4. Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
5. Left atrial anteroposterior diameter >55 mm.
6. Unstable angina.
7. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
8. Previous catheter ablation or surgical ablation for atrial fibrillation.
9. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
10. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
11. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
12. Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
13. Active systemic infection.
14. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
15. Severe hepatic dysfunction.
16. Pregnancy or breastfeeding.
17. Life expectancy <12 months (e.g., advanced malignancy).
18. Current or anticipated participation in other drug or device clinical trials.
19. Any other condition or abnormality deemed by the investigator to warrant exclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: superior vena cava isolation; 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; 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.
Active Comparator: superior vena cava and left atrial posterior wall isolation; 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; 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.; Procedure: Abnormal left atrial substrate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute pulmonary vein ablation success rate and superior vena cava isolation rate.	Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage < 0.1 mV). Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block).	Immediately post-procedure
Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)	Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage < 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing.	Immediately post-procedure
Procedure-related time	Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.	Immediately post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)	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.	Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period	Within 12 months post-procedure
Incidence of repeat ablation after the blanking period	Incidence of repeat ablation after the blanking period	Within 12 months post-procedure
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.	Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.	Within 12 months post-fist procedure.
Improvement in Atrial fibrillation burden.	Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography.	3、6 and 12 months post-procedure.
Cardiac function assessment by NYHA	Cardiac function was assessed relative to baseline using the NYHA classification.	within 12 months post-procedure
The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.	Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score.	Within 12 months post-procedure

Collaborators and Investigators

• Sponsor: Hangzhou Dinova EP Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: EP-CP-IIS-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No