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Clinical Trials in China / NCT07153718
Active, not recruiting Not applicable

Optimal Ablation Strategies for Persistent AF With HF

NCT07153718 · tracked via the Priya Life Science China tracker
Sponsor
Xu Liu
Phase
Not applicable
Started
2021-01-01
Last updated
2025-09-04

Condition(s) studied

Heart FailurePersistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

Electrogram-guided ablationAnatomical-guided AblationExtensive electrogram-anatomical guided ablation

Electrogram-guided ablation: pulmonary vein ioslation; target electrograms ablation, including (1) Spatial-temporal Dispersion Activation, (2) Locally Short Cycle Length Activity, (3) High-Frequency Potentials, (4) Focal Activity.

Anatomical-guided Ablation: pulmonary vein isolation; LA roof, posterior inferior wall and mitral isthmus linear lesion; Vein of Marshall (VOM) ethanol infusion.

Extensive electrogram-anatomical guided ablation: pulmonary vein isolation; target electrogram ablation; linear ablation

Study summary

Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis. Catheter ablation has been shown to improve outcomes in this population, enhancing ablation success rates in these patients is critical for further reducing morbidity and mortality. We conducted this multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * All inclusion criteria must be met to be included in the study. 1. Age: Patients aged 18-80 years, with persistent atrial fibrillation (AF) and heart failure (HF), regardless of ejection fraction (EF). 2. Diagnosis of Heart Failure: Heart Failure with Reduced Ejection Fraction (HFrEF): LVEF ≤ 40%. Heart Failure with Preserved Ejection Fraction (HFpEF): LVEF \> 40%, including HFmrEF (LVEF 41-50%). 3. Symptomatic Atrial Fibrillation: Patients with symptomatic persistent AF who have failed or are intolerant to at least one antiarrhythmic drug. 4. NYHA Class II-III: Patients with heart failure classified as NYHA class II-III, who are symptomatic despite optimal medical therapy. Informed Consent: Able to provide written informed consent for participation in the study. 5. Guideline-Recommended Pharmacologic Therapy: Patients who have received and are currently on guideline-recommended pharmacologic therapy for heart failure, including but not limited to ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists (MRAs). Exclusion Criteria: * Any of the following criteria shall be excluded. 1. End-Stage Heart Failure: Patients with heart failure classified as NYHA class IV or with LVEF ≤ 20%. 2. Severe Comorbidities: 3. Patients with severe pulmonary disease (e.g., COPD, severe restrictive lung disease). 4. Severe renal dysfunction (eGFR \< 30 mL/min/1.73m²) or advanced liver disease. 5. Active malignancy or other terminal illnesses with a prognosis of less than one year. 6. Inability to Tolerate Ablation: <!-- --> 1. Patients unable to undergo catheter ablation due to anatomical or procedural issues. 2. Patients with contraindications to the procedure, including allergy to contrast agents or inability to tolerate anesthesia. 3. Left atrial thrombus confirmed by preoperative esophageal ultrasound; 7. Uncontrolled Arrhythmias: Patients with persistent or paroxysmal AF who are unable to maintain sinus rhythm despite optimal medical therapy or require frequent hospitalization for arrhythmia control. 8\. Pregnancy: Pregnant or breastfeeding women. 9. Contraindications to Anticoagulation: 10. Patients who are contraindicated for anticoagulation therapy (e.g., history of major bleeding or bleeding diathesis). 11\. History of Severe Valve Disease: Patients with a history of severe valve disease and/or prosthetic valve replacement. 12\. Recent Myocardial Infarction or Stroke: Patients who have had a myocardial infarction or stroke within the past 3 months. 13\. Contrast Agent Allergy: Patients with a known allergy to contrast agents. 14. Contraindications for Cardiac Catheterization: Any contraindications for cardiac catheterization, including inability to safely perform the procedure. 15\. Atrial Fibrillation Ablation: Patients who have previously undergone atrial fibrillation ablation. 16\. Cardiac Surgery: Patients who have undergone any cardiac surgery within the last 2 months. 17\. Life Expectancy: Patients with a life expectancy of less than 1 year.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
The PLA Navy Anqing Hospital Anqing Anhui
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Changshu Hospital of Traditional Chinese Medicine Changshu Jiangsu
Xuzhou Central Hospital Xuzhou Jiangsu
Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine Jinan Shandong
Jinan City People's Hospital Jinan Shandong
Affiliated Hospital of Jining Medical University Jining Shandong
Yuhuan Second People's Hospital Yuhuan Zhejiang
Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital Shanghai China
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China

More Xu Liu trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07153718 on ClinicalTrials.gov ↗ ← All trials in China