An interventional study of Electrogram-guided ablation and Anatomical-guided Ablation in Heart Failure and Persistent Atrial Fibrillation, sponsored by Xu Liu. Active, not recruiting at 10 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Xu Liu · Not applicable, Interventional, and Treatment
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.
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 stroke and rehospitalization. Catheter ablation has been shown to improve outcomes in this population, as evidenced by numerous pivotal studies, such as CASTLE-AF. It is well recognized that the majority of patients with HF and AF exhibit persistent AF; however, the underlying mechanisms responsible for sustaining persistent AF in this population remain to be fully elucidated. Thus, enhancing ablation success rates in these patients is therefore critical for further reducing morbidity and mortality.
Building on prior research, we have identified driver regions as critical determinants in the maintenance of persistent atrial fibrillation. Moreover, our randomized controlled trials have demonstrated that electro-anatomical ablation may represent the optimal strategy for persistent AF. Based on these findings, we conducted a multicenter, randomized clinical trial to systematically evaluate the optimal ablation strategy in patients with heart failure and persistent AF.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 300 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Xu Liu is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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All inclusion criteria must be met to be included in the study.
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%).
Exclusion Criteria:
Any of the following criteria shall be excluded.
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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.
Patients in the ANAT group would receive anatomical-guided ablation after PVI, including linear ablation and Vein of Marshall (VOM) ethanol infusion.
Procedure: Anatomical-guided Ablation
Patients in the EGM group received target electrogram ablation after PVI while did not receive anatomical-guided ablation. We defined the target electrograms into 4 types as follows.(1) Spatial-temporal Dispersion Activation (2) Locally Short Cycle Length Activity (3) High-Frequency Potentials (4) Focal Activity
Procedure: Electrogram-guided ablation
Patients in the extensive ablation group (EXT group) would receive EGM-guided ablation firstly. The anatomical-guided ablation would be performed after EGM-guided ablation no matter whether AF terminated during EGM-guided ablation.
Procedure: Extensive electrogram-anatomical 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.
pulmonary vein isolation; LA roof, posterior inferior wall and mitral isthmus linear lesion; Vein of Marshall (VOM) ethanol infusion.
pulmonary vein isolation; target electrogram ablation; linear ablation
a composite of cardiovascular mortality, hospitalization or urgent visits
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
Time frame: 12, 18, 24, 36, 46, 60months
freedom from any documented AF/AT
freedom from any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment
Time frame: 12, 18, 24, 36, 48, 60months
AF burden <1%
AF burden \<1% after a single ablation procedure, as measured by Holter monitoring or device-recorded data (Patients who remained in persistent AF throughout follow-up were assigned AF burden=100%. Both ends of the distribution (burden=0% and burden=100%) were included in statistical analysis.).
Time frame: 12, 24, 36, 48, 60 months after a single procedure
Improvement in New York Heart Association (NYHA) functional class
Improvement in New York Heart Association (NYHA) functional class by at least one grade
Time frame: 12, 24, 36, 48, 60 months after a single procedure
Change in 6-minute walk test
Change in 6-minute walk test from baseline to Month 3, 12, 24, 36, 48, 60 months after a single procedure
Time frame: 12, 24, 36, 48, 60 months after a single procedure
Change in N-terminal pro-B type natriuretic peptide (NT-proBNP)
Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) from baseline to Month 3,12, 24, 36, 48, 60 after a single procedure
Time frame: Month 3,12, 24, 36, 48, 60 after a single procedure
Incidence of procedure-related complications
Incidence of procedure-related complications, including but not limited to: vascular complications (e.g., hematoma, pseudoaneurysm), cardiac tamponade, stroke or transient ischemic attack (TIA), phrenic nerve injury, atrioesophageal fistula, procedure-related death within 30 days.
Time frame: 30 days after a single procedure
Plan to share: No — The individual participant data (IPD) from this study will not be shared publicly due to concerns regarding patient confidentiality and the sensitive nature of medical data. Given the potential risks of identifying participants from detailed clinical information, the data will remain confidential and will not be made available for public sharing. Additionally, the study involves proprietary methodologies and ongoing analyses that are part of the intellectual property of the institution. As such, sharing the IPD at this stage could compromise the integrity of the study's findings and its future applications.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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