Optimal Ablation Strategies for Persistent AF With HF

NCT ID: NCT07153718

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-12-31

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 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.

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 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.

Conditions

Heart Failure; Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anatomical-guided Ablation Group

Patients in the ANAT group would receive anatomical-guided ablation after PVI, including linear ablation and Vein of Marshall (VOM) ethanol infusion.

Group Type: ACTIVE_COMPARATOR

Anatomical-guided Ablation

Intervention Type: PROCEDURE

pulmonary vein isolation; LA roof, posterior inferior wall and mitral isthmus linear lesion; Vein of Marshall (VOM) ethanol infusion.

Electrogram-guided Ablation Group

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

Group Type: ACTIVE_COMPARATOR

Electrogram-guided ablation

Intervention Type: PROCEDURE

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.

Extensive Electrogram-Anatomical Guided Ablation Group

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.

Group Type: EXPERIMENTAL

Extensive electrogram-anatomical guided ablation

Intervention Type: PROCEDURE

pulmonary vein isolation; target electrogram ablation; linear ablation

Interventions

Electrogram-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.

Intervention Type: PROCEDURE

Anatomical-guided Ablation

pulmonary vein isolation; LA roof, posterior inferior wall and mitral isthmus linear lesion; Vein of Marshall (VOM) ethanol infusion.

Intervention Type: PROCEDURE

Extensive electrogram-anatomical guided ablation

pulmonary vein isolation; target electrogram ablation; linear ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xu Liu

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The PLA Navy Anqing Hospital

Anqing, Anhui, China

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

Wuhan, Hubei, China

Changshu Hospital of Traditional Chinese Medicine

Changshu, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

Jinan City People's Hospital

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Yuhuan Second People's Hospital

Yuhuan, Zhejiang, China

Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital

Shanghai, , China

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

EXT- AF&HF

Identifier Type: -

Identifier Source: org_study_id