NCT07153718Active, not recruiting
Optimal Ablation Strategies for Persistent AF With HF
Optimal Ablation Strategies for Persistent Atrial Fibrillation With Heart Failure - Optimization of Intervention Strategies for Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 4 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 26 Aug 2025
- Start date
- 1 Jan 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Xu Liu
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07153718
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 1 Jan 2021 to the primary completion date, 31 Dec 2026
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Any of the following criteria shall be excluded.
- End-Stage Heart Failure: Patients with heart failure classified as NYHA class IV or with LVEF ≤ 20%.
- Severe Comorbidities:
- Patients with severe pulmonary disease (e.g., COPD, severe restrictive lung disease).
- Severe renal dysfunction (eGFR \< 30 mL/min/1.73m²) or advanced liver disease.
- Active malignancy or other terminal illnesses with a prognosis of less than one year.
- Inability to Tolerate Ablation:
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- Patients unable to undergo catheter ablation due to anatomical or procedural issues.
- Patients with contraindications to the procedure, including allergy to contrast agents or inability to tolerate anesthesia.
- 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.
Who the study is looking for
- All inclusion criteria must be met to be included in the study.
- Age: Patients aged 18-80 years, with persistent atrial fibrillation (AF) and heart failure (HF), regardless of ejection fraction (EF).
- 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%).
- Symptomatic Atrial Fibrillation: Patients with symptomatic persistent AF who have failed or are intolerant to at least one antiarrhythmic drug.
- 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.
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The PLA Navy Anqing Hospital Coordinator of this site? Confirm its status | Anqing | China | Unknown status |
| Changshu Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Changshu | China | Unknown status |
| Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jinan City People's Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Yuhuan Second People's Hospital Coordinator of this site? Confirm its status | Yuhuan | China | Unknown status |
Related publications
- Optimal Ablation Strategies for Persistent Atrial Fibrillation With Heart Failure: Three-Year Follow-Up of a Prospective Multicenter Randomized Trial.Circ Arrhythm Electrophysiol · 2026 · PMID 41914182
This page is information, not medical advice. Discuss any trial with your doctor.