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

Official title

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

Overview

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.

Detailed description

No other detailed description.

Interventions

• 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.

Primary outcome measures

• 12-month atrial fibrillation (AF) ablation success rate [Time frame: 12 months post-procedure]

Secondary outcome measures (10)

• Acute pulmonary vein ablation success rate and superior vena cava isolation rate. [Time frame: Immediately post-procedure]
• Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only) [Time frame: Immediately post-procedure]
• Procedure-related time [Time frame: Immediately post-procedure]
• Early recurrence rate of atrial arrhythmia (within the blanking period) [Time frame: Within 3 months post-procedure]
• Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period. [Time frame: Within 12 months post-procedure]
• Incidence of repeat ablation after the blanking period [Time frame: 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. [Time frame: Within 12 months post-fist procedure.]
• Improvement in Atrial fibrillation burden. [Time frame: 3、6 and 12 months post-procedure.]
• Cardiac function assessment by NYHA [Time frame: within 12 months post-procedure]
• The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale. [Time frame: Within 12 months post-procedure]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Pregnancy or breastfeeding.
• Life expectancy <12 months (e.g., advanced malignancy).
• Current or anticipated participation in other drug or device clinical trials.
• Any other condition or abnormality deemed by the investigator to warrant exclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fuwai Yunnan Hospital — Kunming

Identifiers

NCT: NCT07590661 · EP-CP-IIS-010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗