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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The PLA Navy Anqing Hospital
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AnqingChinaUnknown status
Changshu Hospital of Traditional Chinese Medicine
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ChangshuChinaUnknown status
Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
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JinanChinaUnknown status
Jinan City People's Hospital
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JinanChinaUnknown status
Affiliated Hospital of Jining Medical University
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JiningChinaUnknown status
Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Xuzhou Central Hospital
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XuzhouChinaUnknown status
Yuhuan Second People's Hospital
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YuhuanChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.