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Status:

ACTIVE_NOT_RECRUITING

Optimal Ablation Strategies for Persistent AF With HF

Lead Sponsor:

Xu Liu

Conditions:

Heart Failure

Persistent Atrial Fibrillation

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief 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 ...

Detailed Description

Atrial fibrillation (AF) in the context of heart failure (HF) is associated with a markedly poor prognosis, with one-year all-cause mortality rates approaching 34% and substantially elevated risks of ...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

  • 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.

Key Trial Info

Start Date :

January 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2026

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT07153718

Start Date

January 1 2021

End Date

December 31 2026

Last Update

September 4 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

The PLA Navy Anqing Hospital

Anqing, Anhui, China, 246000

2

The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430014

3

Changshu Hospital of Traditional Chinese Medicine

Changshu, Jiangsu, China, 215516

4

Xuzhou Central Hospital

Xuzhou, Jiangsu, China, 221009