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:
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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)
a composite of cardiovascular mortality, hospitalization or urgent visits — 12, 18, 24, 36, 46, 60months The primary endpoint was the incidence of a composite of cardiovascular mortality, hospitalization or urgent visits due to worsening heart failure during the follow-up period after a single catheter ablation procedure
freedom from any documented AF/AT — 12, 18, 24, 36, 48, 60months freedom from any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment
Trial sites (10)
Facility
City
Region
Status
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
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.
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